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‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ‬

‫م‬2019 ‫ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ ﻟﻌﺎم‬


Special Conditions and Terms of Supply for the Tender of
Medical Devices 2019

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 1 of 21
Special Terms & Conditions for Tender of Medical ‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬
Devices
1. The attached specifications shall constitute the ‫ اﻟﻤﻮاﺻـــــــﻔــﺎت اﻟﻤﺮﻓﻘــﺔ ﻫﻲ اﻟﺤــﺪ اﻷدﻧﻰ ﻟﻤﺘﻄﻠﺒــﺎت ﻣﺠﻠﺲ‬.1
minimum requirements imposed by the GCC Health ‫ﻘﺪم‬
ّ ُ‫اﻟﺼــﺤﺔ ﻟﺪول ﻣﺠﻠﺲ اﻟﺘﻌﺎون وﻋﻠﻰ اﻟﺸــﺮﻛﺔ اﻟﺼــﺎﻧﻌﺔ أن ﺗ‬
Council, and the concerned manufacturer shall ‫اﻟﻤﻠﺤﻘﺎت‬ ُ ‫ــــــﺎﻣﻠﺔ ﺟﻤﻴﻊ‬
ً ‫ ﺷـ‬،FDA, CE ‫اﻷﺟﻬﺰة اﻟﺤﺪﻳﺜﺔ اﻟﻤﻄﺎﺑﻘﺔ‬
provide the latest medical devices that conform to the ‫واﻹﻛﺴﺴﻮرات اﻟﺘﻲ ﺗُ ﻤ ّﻜﻦ ﻣﻦ اﻻﺳﺘﻔﺎدة اﻟﻜﺎﻣﻠﺔ ﻟﻠﻤﻌﺪات أو‬
FDA & CE standards, including all accessories which ‫ ﺑﺎﻹﺿـــــــﺎﻓﺔ إﻟﻰ ﺗﻘﺪﻳﻢ ﺷـــــــﻬﺎدة اﻋﺘﻤﺎد اﻟﺠﻬﺎز ﻟﻠﺒﻴﻊ‬،‫اﻷﺟﻬﺰة‬
enable the full advantage of the equipment/devices. ‫واﻻﺳـــــــﺘﺨﺪام ﻣﻦ ﻫﻴﺌﺔ اﻟﻐﺬاء واﻟﺪواء اﻟﺴـــــــﻌﻮدﻳﺔ أو اﻟﺠﻬﺎت‬
In addition, an approval certificate of sale or use ‫اﻟﻤﻌﻨﻴﺔ ﻓﻲ اﻟﺪول اﻷﻋﻀﺎء‬
issued by the SFDA or the concerned entities in the
Member States shall be provided.
2. The concerned manufacturer shall visit the location ‫واﻻﻃﻼع ﻋﻠﻰ‬
ّ ‫ ﻋﻠﻰ اﻟﺸــــــﺮﻛــﺔ اﻟﺼــــــــﺎﻧﻌــﺔ زﻳــﺎرة اﻟﻤﻮﻗﻊ‬.2
and acquaint itself with the conditions accompanying ‫اﻟﻈﺮوف اﻟﻤﺤﻴﻄــﺔ ﺑــﺎﻟﻌﻤﻠﻴــﺔ ﻣﻦ ﻧــﺎﺣﻴــﺔ ﺗﻮﺻــــــﻴــﻞ اﻟﻤــﺎء‬
the installation/operation process in terms of water, ‫واﻟﻜﻬﺮﺑﺎء أو أي أﻋﻤﺎل أﺧﺮى ﺗﺤﺘﺎﺟﻬﺎ اﻷﺟﻬﺰة ﻣﻦ ﻣﺼــﺪرﻫﺎ‬
electricity or other services needed for the devices ‫ﺑﻨﺎء ﻋﻠﻰ ﺗﻘﺪﻳﺮاﺗﻪ ﻟﻠﺘﻜﺎﻟﻴﻒ واﻻﻟﺘﺰاﻣﺎت‬
ً ‫ووﺿــﻊ أﺳــﻌﺎرﻫﺎ‬
and the manufacturer shall then determine the prices ‫ وﻋﻠﻴــﻪ ﻓــﺈن ﺟﻤﻴﻊ ﻣﺼــــــــﺎرﻳﻒ ﻣــﺎ ﻗﺒــﻞ‬،‫اﻟﻤﻄﻠﻮﺑــﺔ ﻣﻨــﻪ‬
based on its assessment of the costs and relevant ‫اﻟﺘﺮﻛﻴﺐ ﻣﻦ أﻋﻤﺎل ﻣﺪﻧﻴﺔ وﻣﻌﻤﺎرﻳﺔ وﻛﻬﺮﺑﺎﺋﻴﺔ وﻣﻴﻜﺎﻧﻴﻜﻴﺔ‬
obligations. Therefore, all pre-installation expenses ‫وﺻـــﺤﻴﺔ وﻏﻴﺮﻫﺎ ﻣﻦ اﻟﻤﺼـــﺎدر اﻟﺮﺋﻴﺴـــﻴﺔ إذا وﺟﺪت وﻓﻲ‬
ّ
including electrical, mechanical and civil engineering ‫ﺣﺎ ﻟﺔ ﻋﺪم ﺗﻮﻓﺮ ﻫﺎ ﻳ ﺠﺐ ﺗﻮﻓﻴﺮ ﻫﺎ ﺑﺎﻟﻤﻮﻗﻊ وذ ﻟﻚ ﻟﺘﺮﻛ ﻴﺐ‬
works and other relevant resources (if any) shall be full ‫ ﻛﻞ ذﻟﻚ ﻫﻮ ﻣﺴــــــﺆوﻟﺔ اﻟﺸــــــﺮﻛﺔ‬،‫اﻟﻤ ﻌﺪات‬
ُ ‫وﺗﺸــــــﻐﻴﻞ‬
responsibility of the manufacturer who shall avail the ‫اﻟﺼــــﺎﻧﻌﺔ ﺑﺎﻟﻜﺎﻣﻞ وﻳﺠﺐ أن ﺗﻜﻮن ﻣﺸــــﻤﻮﻟﺔ اﻟﺴــــﻌﺮ ﻓﻲ‬
same in the location for the installation and operation ‫ﻋﺮﺿــــــﻪ ﻛﻤﺎ ﻳﺠﺐ أن ﺗﻜﻮن ﺟﻤﻴﻊ اﻟﺘﺸــــــﻄﻴﺒﺎت اﻟﺨﺎﺻــــــﺔ‬
of the equipment. All the relevant ancillary works shall ‫ﺑﺎﻟﻤﻮﻗﻊ ﻣﺘﻼﺋﻤﺔ وﻣﻨﺪﻣﺠﺔ ﻣﻊ اﻟﺸــــــﻜﻞ اﻟﻌﺎم ﻟﻠﻘﺴــــــﻢ‬
be included in the price provided in the bidder's bid, ‫واﻟﻤ ﺴﺘ ﺸﻔﻰ ﺑ ﺸﻜﻞ ﻋﺎم ) وإزاﻟﺔ ﺟﻤﻴﻊ اﻷﺟﻬﺰة اﻟﻘﺪﻳﻤﺔ‬
and the location's finishing shall be suitable and ‫ﻣﻊ ﺗﻮﺻــﻴﻠﻬﺎ ﺑﺎﻟﻄﺮﻳﻘﺔ اﻟﺴــﻠﻴﻤﺔ ﺣﺴــﺐ اﻟﻄﻠﺐ ( ﺣﻴﺚ ﻟﻦ‬
integrated with the general appearance of the ‫ﺗﻘﺒﻞ أي أﻋﺬار ﺑﻌﺪ ﺗﻘﺪﻳﻢ اﻟﻌﺮوض وﻳﺠﺐ إرﻓﺎق ﺷـــــﻬﺎدة‬
department and hospital in general (and all old .‫زﻳﺎرﺗﻪ ﻟﻠﻤﻮﻗﻊ‬
devices shall be removed and delivered in an
appropriate way and as requested) where no excuses
will be accepted after the submission of bids.
Manufacturer must attach a certificate to provide that
a visit was conducted to the relevant location.
3. The concerned company shall coordinate with the ‫ ﻋﻠﻰ اﻟﺸــــــﺮﻛﺔ اﻟﺘﻨﺴــــــﻴﻖ ﻣﻊ اﻟﺪول اﻷﻋﻀـــــــﺎء واﻟﺠﻬﺎت‬.3
Member States (MPs) and Participating Parties (PPs) ‫اﻟﻤﺸــــــــﺎرﻛــﺔ ﺑﺨﻄــﺎﺑــﺎت رﺳــــــﻤﻴــﺔ ﻟﺘﻮﺟﻴــﻪ ﺟﻤﻴﻊ اﻟﻤﻌﻨﻴﻴﻦ‬
through official letters in order to direct all concerned (‫ ﻣﻴﻜﺎﻧﻴﻜﻴﻴﻦ‬،‫ ﻛﻬﺮﺑﺎﺋﻴﻴﻦ‬،‫ ﻣﺪﻧﻴﻴﻦ‬،‫ ﻃﺒﻴﻴﻦ‬،‫)اﻟﻤﻬ ﻨﺪﺳــــــﻴﻦ‬
individuals (engineers, doctors, civil workers, .‫ﺑﺘﻮاﺟﺪﻫﻢ ﻓﻲ اﻟﻤﻮﻗﻊ اﻟﻤﺮاد ﻟﺘﺮﻛﻴﺐ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬
electricians and technicians) to be present in the
location where the medical devices will be installed.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 2 of 21
4. The concerned manufacturer shall provide all required ‫ ﺗﻠﺘﺰم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺘﻮﻓﻴﺮ ﺟﻤﻴﻊ ﻗﻄﻊ اﻟﻐﻴﺎر اﻟﻤﻄﻠﻮﺑﺔ‬.4
spare parts at its own account in order to perform the ‫ﺨﻄﻂ ﻟﻬـﺎ‬ ُ ‫ﻋﻠﻰ ﺣﺴـــــــﺎﺑﻬــﺎ ﻹﺟﺮاء اﻟﺼــــــﻴــﺎﻧـﺔ اﻟﻮﻗـﺎﺋﻴــﺔ‬
ّ ‫اﻟﻤ‬
planned preventive and routine maintenance works, ‫واﻟﺼــــــﻴﺎﻧﺔ اﻟﺮوﺗﻴﻨﻴﺔ ﻋﻠﻰ أن ﺗﻜﻮن ﺟﺎﻫﺰة ﻋﻨﺪ اﻟﺤﺎﺟﺔ إﻟﻴﻬﺎ‬
provided that such parts shall be ready immediately ‫ﻘﺪم ﻣﻨﻪ ﻟﻠﺼــــــﻴﺎﻧﺔ ﺑﺄﻧﻮاﻋﻬﺎ‬ ّ ‫اﻟﻤ‬ ً
ُ ‫ﻓﻮرا وﺣﺴـــــــﺐ اﻟﺒﺮﻧﺎﻣﺞ‬
upon need and according to the Scheduled ‫ﺣﺴﺐ ﺗﻮﺻﻴﺎت اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻃﻮال ﻓﺘﺮة اﻟﻀﻤﺎن ﺑﻤﺎ‬
Maintenance Program of various types as provided by ‫ﻓﻴﻬﺎ اﻟﻤﺴــــﺘﻬﻠﻜﺎت اﻟﺨﺎﺻــــﺔ ﺑﺎﻟﺼــــﻴﺎﻧﺔ )ﻳﺴــــﺘﺜﻨﻰ ﻓﻘﻂ‬
the manufacturer throughout the warranty period, ‫ﻣﺴـــــﺘﻬﻠﻜﺎت اﻟﺘﺸـــــﻐﻴﻞ ﻣﺜﻞ اﻹﻟﻜﺘﺮوﻧﺎت وأوراق اﻟﻄﺒﺎﻋﺔ‬
including the consumables related to maintenance .(‫واﻷﺣﺒﺎر‬
(excluding only the operation consumables such as
electrons, printing sheets and inks).
5. The concerned manufacturer shall perform ‫ ﻋﻠﻰ اﻟﺸـــﺮﻛﺔ اﻟﺼـــﺎﻧﻌﺔ ﺻـــﻴﺎﻧﺔ ﺟﻤﻴﻊ اﻷﺟﻬﺰة وذﻟﻚ ﺧﻼل‬.5
maintenance for all devices within the warranty ‫ﻓﺘﺮة اﻟﻀـــــﻤﺎن وﻫﺬا ﻳﺸـــــﻤﻞ أﻋﻤﺎل اﻟﻤﻌﺎﻳﻨﺔ واﻟﺼـــــﻴﺎﻧﺔ‬
period; this shall include the regular and preventive ‫ﺤﺪد‬
ّ ‫اﻟﻤ‬
ُ ‫ا ﻟﺪور ﻳﺔ اﻟﻮ ﻗﺎﺋ ﻴﺔ واﻟﻤ ﻌﺎﻳﺮة واﻟﺼــــــ ﻴﺎ ﻧﺔ اﻟ ﻄﺎر ﺋﺔ‬
testing and maintenance works, calibration and 48- ‫ ﺳـــــــﺎﻋﺔ وﺗﻮﻓﻴﺮ ﺟﻤﻴﻊ ﻣﺎ ﻳﻠﺰم‬48 ‫اﻻﺳــــــﺘﺠﺎﺑﺔ ﻟﻬﺎ ﺧﻼل‬
hours emergency maintenance along with the ‫ ﻣﻊ ﺿــــﺮورة اﻟﺘﻨﺴــــﻴﻖ ﻣﻊ إدارة اﻟﺼــــﻴﺎﻧﺔ ﺑﺎﻟﻤﻮﻗﻊ‬،‫ﻟﺬﻟﻚ‬
provision of all required services, provided that the ‫اﻟﺘﻌﻄﻞ إﻟﻰ ﻣﺪة‬
ّ ‫ﺗﺄﺧﺮ ﻋﻦ ذﻟﻚ ﺗُ ﻀــﺎف ﻣﺪة‬
ّ ‫ﻗﺼــﺮ أو‬
ّ ‫وإذا‬
manufacturer must coordinate with the Maintenance ‫اﻟﻀـــﻤﺎن ﻋﻠﻰ أن ﺗﻘﻮم اﻟﺠﻬﺔ اﻟﻤﺸـــﺎرﻛﺔ ﺑﺈﺻـــﻼح اﻟﻌﻄﻞ‬
Dept. in the location and if it failed or delayed the ‫ﻋﻠﻰ ﺣﺴـــﺎﺑﻪ وﺗُ ﻮﻗﻊ ﻋﻠﻴﻪ اﻟﺤﺴـــﻢ اﻟﻤﻨﺎﺳـــﺐ ﺣﺴـــﺐ ﺑﻨﻮد‬
provision or such services the disruption period shall .‫اﻟﻌﻘﺪ‬
be added to the warranty period, and the Participating
Party will procure maintenance at the manufacturer's
expense and shall impose the appropriate deduction
as per the contracts terms.
6. All maintenance works shall be fully performed in a ‫ ﻳﺠﺐ أن ﺗﺘﻢ أﻋﻤﺎل اﻟﺼــﻴﺎﻧﺔ ﺑﻜﺎﻣﻠﻬﺎ ﺑﺸــﻜﻞ ﻣﻬﻨﻲ وﻛﺎﻣﻞ‬.6
ً
professional manner to the highest standards and in ‫ﻃﺒﻘﺎ ﻟﻤﻤﺎرﺳــﺎت وأﺻــﻮل اﻟﺘﺼــﻨﻴﻊ‬ ‫وذات ﻣﻘﺎﻳﻴﺲ ﻋﺎﻟﻴﺔ‬
accordance with the best manufacturing and .‫واﻟﺼﻴﺎﻧﺔ اﻟﻤﻤﺘﺎزة‬
maintenance practices.
7. In case the concerned manufacturer failed to perform ‫ ﻓﻲ ﺣﺎﻟﺔ ﺗﻘﺼــــــﻴﺮ اﻟﺸــــــﺮﻛﺔ اﻟﺼـــــــﺎﻧﻌﺔ ﻋﻦ إﺗﻤﺎم أﻋﻤﺎل‬.7
the required preventive or corrective maintenance ‫اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ أو اﻟﺘﺼﺤﻴﺤﻴﺔ )وإﺻﻼح اﻷﻋﻄﺎل( ﺳﻴﺘﻢ‬
works (and repair of faults) the Default Fine shall be ‫ﺗﻄﺒﻴﻖ ﻏﺮاﻣــﺔ ﺗﻘﺼــــــﻴﺮ وﻓﻘـ ًـﺎ ﻟﻠﺘﻔــﺎﺻــــــﻴــﻞ اﻟﻮاردة ﻓﻲ‬
imposed in accordance with the provisions contained .‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ‬
in the Special Conditions.
8. The concerned manufacturer shall provide the ‫ ﺗﻠﺘﺰم اﻟﺸــﺮﻛﺔ اﻟﺼــﺎﻧﻌﺔ ﺑﺘﻘﺪﻳﻢ اﻟﻤﺴــﺘﻬﻠﻜﺎت اﻟﺘﺸــﻐﻴﻠﻴﺔ‬.8
operation consumables for the device and its ‫ﻟﻠﺠﻬﺎز وﻣﻠﺤﻘﺎﺗﻪ ﻟﻤﺪة ﻻ ﺗﻘﻞ ﻋﻦ ﺳــــــﺘﺔ أﺷــــــﻬﺮ وﺗﻜﻮن‬
accessories for a period of no less than six (6) months, ‫ﺑﻨﺎء ﻋﻠﻰ اﻻﺳــــــﺘﻬﻼك ﻟﻜﻞ ﺟﻬﺔ‬
ً ‫اﻟﻤﺴــــــﺘﻬﻠﻜﺎت ﻣﺠﺎﻧﻴﺔ‬
and such consumables shall be free of charge based .‫ﻣﺸﺎرﻛﺔ ﻣﻊ ﺗﻘﺪﻳﻢ ﻗﺎﺋﻤﺔ ﺑﺬﻟﻚ ﻓﻲ اﻟﻌﺮض اﻟﻤﻘﺪم‬
on consuming rate by each Participating Party. A list of
consumables shall be submitted along with the
relevant bid.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 3 of 21
9. Devices shall be compatible with the Modern Digital ‫ اﻷﺟﻬﺰة ﻳﺠـــﺐ أن ﺗﻜﻮن ﻣﺘﻮاﻓﻘـــﺔ ﻣﻊ ﻧﻈـــﺎم اﻟﺘﻘﻨﻴـــﺎت‬.9
Technique System and Electronic Archiving System for ‫اﻟﺮﻗﻤﻲ اﻟﺤـﺪﻳـﺚ وﻧﻈـﺎم اﻷرﺷــــــﻔـﺔ اﻹﻟﻜﺘﺮوﻧﻴـﺔ ﻟﺼــــــﻮر‬
X-rays; they must include the features of integration ‫اﻷ ﺷﻌﺔ ﻣﻊ اﻟﺘﺰاﻣﻪ ﺑﻌﻤﻞ اﻟﺘﻜﺎﻣﻞ واﻟﺘﻮﺣﻴﺪ واﻻﻧﺪﻣﺎج ﻣﻊ‬
and unification with the other devices and solutions ‫اﻷﺟﻬﺰة واﻟﺤﻠﻮل اﻷﺧﺮى ﻓﻲ اﻟﻤﻮﻗﻊ ﺳـــﻮاء اﻟﻤﻮﺟﻮدة أو‬
available in the site or those to be provided in the site .‫اﻟﺘﻲ ﺳﻮف ﺗﻮﺟﺪ ﺑﺎﻟﻤﻮﻗﻊ‬
in future.
10. Radiation shields for all parts and electric switches ‫ ﻋﻤﻞ اﻟﺪروع اﻟﻮاﻗﻴﺔ ﻣﻦ اﻹﺷــــﻌﺎﻋﺎت واﻟﺘﺮﺻــــﻴﺺ ﻟﺠﻤﻴﻊ‬.10
shall be provided in accordance with the capacity of ‫ﻘﺪم وذﻟﻚ‬
ّ ‫اﻟﻤ‬
ُ ‫ﻗﻮة اﻟﺠﻬﺎز‬
ّ ‫أﺑﻌﺎد وﻣﻔﺎﺗﻴﺢ اﻟﻜﻬﺮﺑﺎء ﺣﺴــــــﺐ‬
the supplied devices through a specialized contractor ‫ﻋﻦ ﻃﺮﻳﻖ ُﻣﻘــﺎول ُﻣ ّﺮﺧﺺ ﻣﻦ ﺟﻬــﺔ رﺳــــــﻤﻴــﺔ ﻓﻲ دول‬
licensed by official entity in the GCC countries. ‫ﻣﺠﻠﺲ اﻟﺘﻌﺎون ﻛﻤﺎ ﻳﺠﺐ ﺗﻘﺪﻳﻢ اﻟﻘﺮاءات اﻟﻼزﻣﺔ ﻟﺴﻼﻣﺔ‬
Moreover, the required measurements of shielding ‫اﻟﺘﺪرﻳﻊ ﻗﺒﻞ وﺿــــﻊ اﻟﺪﻳﻜﻮرات واﻟﺪﻫﺎﻧﺎت اﻟﻨﻬﺎﺋﻴﺔ ﻟﺘﺘﻤﻜﻦ‬
integrity shall be provided before installation of ‫اﻟﺠﻬﺔ اﻟﻤﺸــــﺎرﻛﺔ ﻣﻦ ﻣﺮاﺟﻌﺘﻬﺎ واﻟﺘﺄﻛﺪ ﻣﻦ ﺳــــﻼﻣﺘﻬﺎ ﻛﻤﺎ‬
decorations and final painting works in order for the ‫ﻳ ﺠﺐ ﺗ ﻘﺪﻳﻢ اﻟﻘﺮاءات اﻟﻨ ﻬﺎﺋ ﻴﺔ ﺑﻌﺪ اﻟﺘﺸــــــﻐ ﻴﻞ اﻟﺘﺠﺮﻳﺒﻲ‬
Participating Party to be able to review and ensure the .‫ﻟﻠﺠﻬﺎز‬
integrity of such works. The final shielding
measurements shall be submitted after the pilot
operation of the device.
11. As for the HIS system for the Participating Party, the ‫ ﻟﻠﺠﻬﺔ اﻟﻤﺸـــﺎرﻛﺔ ﻳﺠﺐ ﻋﻠﻰ اﻟﺸـــﺮﻛﺔ‬HIS ‫ ﺑﺎﻟﻨﺴـــﺒﺔ ﻟﻨﻈﺎم‬.11
concerned manufacturer shall take into account the ‫ ﻋﻨـــﺪ وﺿــــــﻊ‬DICOM ‫اﻟﺼـــــــــﺎﻧﻌـــﺔ اﻷﺧـــﺬ ﻓﻲ اﻻﻋﺘﺒـــﺎر‬
DICOM system upon setting the devices specifications, ‫اﻟﻤﻮاﺻـــــﻔﺎت وأي ﺟﻬﺎز ﻳﺤﺘﺎج إﻟﻰ اﻟﺮﺑﻂ ﻻ ُﺑ ّﺪ ﻣﻦ وﺿـــــﻊ‬
and any devices that needs to be connected must ‫ ﺿﻤﻦ اﻟﺠﻬﺎز و ﺳﻮف ﻳ ﺴﺘﺒﻌﺪ أي ﺟﻬﺎز‬Interface ‫ﺧﺎ ﺻﻴﺔ‬
include the "Interface" features. Any device that does ‫ﻻ ﻳﺤ ﻤﻞ ﻫﺬه اﻟﺼــــــ ﻔﺔ وﻳ ﺠﺐ إﺣﻀـــــــﺎر ﺗﻌ ﻬﺪ ﺑﺄن ﺟﻤﻴﻊ‬
not include such feature shall be excluded and an ‫اﻷﺟﻬﺰة اﻟﻄﺒﻴــﺔ اﻟﺘﻲ ﻳﻤﻜﻦ رﺑﻄﻬــﺎ ﺑﺸــــــﺒﻜــﺔ اﻟﻤﻌﻠﻮﻣــﺎت‬
undertaking shall be provided by the manufacturer / (DICOM) ‫ﺑﺎﻟﻤﺴـــﺘﺸـــﻔﻰ ﻳﺠﺐ أن ﺗﺤﺘﻮي ﻋﻠﻰ ﺧﺎﺻـــﻴﺔ‬
that all medical devices can be connected to the ‫( واﻷﻧﻈﻤﺔ اﻷﺧﺮى اﻟﻤﻌﻤﻮل ﺑﻬﺎ داﺧﻞ‬IHE) ‫اﻟﻤﺘﻮاﻓﻖ ﻣﻊ‬
hospital's database systems, and that the medical .‫دول ﻣﺠﻠﺲ اﻟﺘﻌﺎون‬
devices includes DICOM features that are compatible
with the IHE system and other systems applicable in
the GCC countries.
12. The concerned manufacturer shall provide a list of the ‫ ﻋﻠﻰ اﻟﺸــــﺮﻛﺔ اﻟﺼــــﺎﻧﻌﺔ ﺗﻘﺪﻳﻢ ﻗﺎﺋﻤﺔ ﺑﺎﻟﻤﻮاﻗﻊ اﻟﻤﺮﺟﻌﻴﺔ‬.12
reference sites of devices in the GCC countries to ‫ﻟﻸﺟﻬﺰة ﺑــﺪول ﻣﺠﻠﺲ اﻟﺘﻌــﺎون اﻟﺨﻠﻴﺠﻲ اﻟﺘﻲ ﺗﻢ ﺗﻮرﻳــﺪ‬
which the tender's devices were supplied, as well as ‫ــﺪﻣـــﺔ ﺑـــﺎﻟﻤﻨـــﺎﻗﺼـــــــــﺔ ﻟﻬـــﺎ وﻛـــﺬﻟـــﻚ ﻧﻈـــﺎم‬
ّ ‫اﻟﻤﻘـ‬
ُ ‫اﻷﺟﻬﺰة‬
the relevant information system. .‫اﻟﻤﻌﻠﻮﻣﺎت‬
13. The concerned manufacturer shall attach to the ‫ ﻋﻠﻰ اﻟﺸــــــﺮﻛــﺔ اﻟﺼــــــــﺎﻧﻌــﺔ أن ﺗُ ﺮﻓﻖ ﻣﻊ اﻟﻌﺮض اﻟﻤــﺎﻟﻲ‬.13
financial and technical offer a certificate which proves ‫اﻟﻤﻨﺸــﺄة‬
ُ ‫واﻟﻔﻨﻲ ﺷــﻬﺎدة ﺗﺜﺒﺖ زﻳﺎرة اﻟﻤﻮﻗﻊ ﻣﻌﺘﻤﺪة ﻣﻦ‬
that the manufacturer visited the site. Such certificate .‫اﻟﻤﺮاد ﺗﺮﻛﻴﺐ اﻟﺠﻬﺎز ﻓﻴﻬﺎ‬
must be attested by the facility where the device to be
installed.
14. A bidder shall arrange its bid as follows: :‫ﻘﺪم اﻟﻌﻄﺎء ﺗﺮﺗﻴﺐ ﻋﺮﺿﻪ ﻛﺎﻟﺘﺎﻟﻲ‬
ّ ‫ ﻋﻠﻰ ُﻣ‬.14

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 4 of 21
A) A file that contains the Cover Letter including the ‫ﻣﻠﻒ ﻳﺤﺘﻮي ﻋﻠﻰ ﺧﻄﺎب اﻟﺘﻐﻄﻴﺔ ﻳﺘﻀــــــﻤﻦ إﺟﻤﺎﻟﻲ‬ .‫أ‬
total price for the bid, bills of quantities, the ‫ﺳــﻌﺮ اﻟﻌﻄﺎء وﺟﺪاول اﻟﻜﻤﻴﺎت واﻟﺸــﻬﺎدات اﻟﻤﻄﻠﻮﺑﺔ‬
required certification, initial guarantee letter and ‫وﺧ ﻄﺎب اﻟﻀــــــ ﻤﺎن اﻻﺑ ﺘﺪاﺋﻲ واﻟﺘﺰام ﻣ ﻘﺪم اﻟﻌ ﻄﺎء‬
undertaking by the bidder to abide by the general ‫واﻟﺨﺎﺻـــــﺔ ﺑﺎﻟﻤﻨﺎﻓﺴـــــﺔ ﻣﻊ ذﻛﺮ أي‬
ّ ‫ﺑﺎﻟﺸـــــﺮوط اﻟﻌﺎﻣﺔ‬
and special conditions of the tender, along with ‫ﺗﺤﻔﻈﺎت أو ﺗﺨﻔﻴﻀـــــــﺎت أو ﺗﻔﺎﺻــــــﻴﻞ ﻋﻠﻰ أﺻـــــــﻞ‬
any reservations, discounts or other details ‫اﻟﻌﺮض اﻟﻤﻘﺪم‬
related to the submitted original bid. ‫ اﻟﻌﺮض‬،‫ ﺗﺴــﻌﻴﺮ اﻟﺒﻨﺪ وﺟﺪاول ﻣﻮاﺻــﻔﺎت ﻣﺠﻠﺲ اﻟﺼــﺤﺔ‬-‫ب‬
B) Pricing schedule for each item, specifications of ‫ ﺷــــــﻬﺎدة ﻗﺒﻮل اﻟﻤﻨﺘﺞ ﻓﻲ‬،‫ اﻟﻜﺘﺎﻟﻮج‬،‫اﻟﻔﻨﻲ اﻟﺘﻔﺼــــــﻴﻠﻲ‬
the GCC Health Council, the detailed technical ‫ وأن ﻳﻜﻮن اﻟﺘﺮﺗﻴﺐ اﻟﻤﺬﻛﻮر ﻟﻜﻞ ﺑﻨﺪ‬SFDA or CE or FDA))
offer, catalogue, and FDA, CE, or SFDA-approved ‫ﻋﻠﻰ ﺣﺪة‬
certificate of acceptance. Each item shall be stated ‫ ﺟﺪول ﺗﺴـــﻌﻴﺮ أﻋﻤﺎل اﻟﺼـــﻴﺎﻧﺔ وﻗﻄﻊ اﻟﻐﻴﺎر وﻋﺮوض ﻋﻘﻮد‬-‫ج‬
separately in the aforementioned order. ‫ ﻏﻴﺮ ﺷــــﺎﻣﻠﺔ( ﻟﻘﻄﻊ اﻟﻐﻴﺎر ﺑﻌﺪ اﻧﺘﻬﺎء ﻓﺘﺮة‬/ ‫اﻟﺼــــﻴﺎﻧﺔ )ﺷــــﺎﻣﻠﺔ‬
C) Maintenance works and spare parts pricing ‫اﻟﻀﻤﺎن‬
schedule and maintenance contracts (both
including/excluding) the spare parts after the
expiry of the warranty period.
SCOPE: :‫ﻧﻄﺎق اﻟﻌﻤﻞ‬
1- Manufacturers shall provide all required labor, ‫ ﻳﺠﺐ ﻋﻠﻰ اﻟﺸﺮﻛﺎت اﻟﺼﺎﻧﻌﺔ ﺗﻮﻓﻴﺮ ﺟﻤﻴﻊ اﻟﻌﻤﺎﻟﺔ واﻟﻤﻮاد‬.1
materials, accessories and additional services for the ‫واﻟﺨــﺎﻣــﺎت واﻟﻤﻠﺤﻘــﺎت اﻹﺿــــــــﺎﻓﻴــﺔ واﻟﺨــﺪﻣــﺎت اﻟﻼزﻣــﺔ‬
devices to be installed and operated, provided that ‫ﻟﻸﺟﻬﺰة اﻟﺘﻲ ﺳــــــﻴﺘﻢ ﺗﺮﻛﻴﺒﻬﺎ وﺗﺸــــــﻐﻴﻠﻬﺎ ﻋﻠﻰ أن ﺗﻜﻮن‬
such labor force shall be specialized and professional. .‫اﻟﻌﻤﺎﻟﺔ ﻣﺘﺨﺼﺼﺔ ﺑﺬﻟﻚ‬
2- The indicated prices shall include the supply and ‫ اﻷﺳــــﻌﺎر اﻟﻤﻮﺿــــﺤﺔ ﻳﺠﺐ أن ﺗﺸــــﻤﻞ ﺗﻮرﻳﺪ ﻫﺬه اﻷﺟﻬﺰة‬.2
installation of the relevant devices in the site ‫وﺗﺮﻛﻴﺒﻬﺎ ﻓﻲ اﻟﻤﻮﻗﻊ اﻟﻤﺤﺪد ﻣﻦ ﻗﺒﻞ اﻟﺠﻬﺔ اﻟﻤﺸـــــــﺎرﻛﺔ‬
determined by the concerned Participating Party, and ‫وﺗﺪرﻳﺐ اﻟﻔﻨﻴﻴﻦ ﻋﻠﻰ اﺳــــــﺘﺨﺪاﻣﻬﺎ واﻟﺘﺸــــــﻐﻴﻞ اﻟﻤﺒﺪﺋﻲ‬
shall include the training of technicians, initial ‫وﺗﻮﺻـــﻴﻼت اﻟﻤﻨﺎﻓﻊ واﻻﺧﺘﺒﺎر واﻟﻨﻘﻞ واﻟﺘﺄﻣﻴﻦ واﻟﺠﻤﺎرك‬
operation, services connections, testing, ‫واﻟﻀــــــﺮاﺋﺐ واﻟﻤﻌﺎﻳﺮة وﻛﻞ ﻣﺎ ﻳﻠﺰم ﻟﺘﺴــــــﻠﻴﻢ اﻟﺠﻬﺎز ﻓﻲ‬
transportation, insurance, customs fees, taxes and .‫درﺟﺔ ﻋﺎﻟﻴﺔ ﻣﻦ اﻟﻜﻔﺎءة ﻣﻊ ﺗﻘﺪﻳﻢ ﺗﻜﻠﻔﺔ ﺗﻘﺪﻳﺮﻳﺔ‬
calibration and all other required matters to deliver
the relevant devices to a high degree of efficiency,
along with a statement on the estimated cost.
3- The relevant devices shall be delivered in an ‫ ﺗﺴﻠﻴﻢ اﻷﺟﻬﺰة ﻓﻲ ﺣﺎﻟﺔ ﺗﺸﻐﻴﻠﻴﺔ ﺑﺎﻟﻜﻔﺎءة اﻟﺘﺎﻣﺔ )اﻟﻜﻔﺎءة‬.3
ً
operational statues fully efficient (the required ‫وﻓﻘﺎ ﻟﻼﻟﺘﺰاﻣﺎت اﻟﺘﻌﺎﻗﺪﻳﺔ( وﺑﺤﻀــــﻮر ﻣﻬﻨﺪس‬ ‫اﻟﻤﻄﻠﻮﺑﺔ‬
efficiency as per the contractual obligations) in the ‫ﻣﻨﺪوب ﻋﻦ اﻹدارة اﻟﻤﺸﺮﻓﺔ ﻓﻲ اﻟﺪول اﻻﻋﻀﺎء واﻟﺠﻬﺎت‬
presence of an engineer delegated by the supervising .‫اﻟﻤﺸﺎرﻛﺔ‬
authority in the Member States and Participating
Parties.
4- A graphical layout shall be prepared in order to ‫ ﻋﻤﻞ ﺗﺨﻄﻴﻂ ﺑﻴﺎﻧﻲ ﻳﻮﺿــــــﺢ ﻛﻴﻔﻴﺔ ﺗﻮزﻳﻊ اﻷﺣﻤﺎل واﻟﺠﻬﺪ‬.4
indicate the distribution of electrical loads and voltage ‫اﻟﻜﻬﺮﺑﺎﺋﻲ داﺧﻞ اﻟﻐﺮﻓﺔ اﻟﻤﺰﻣﻊ ﺗﺮﻛﻴﺐ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ ﺑﻬﺎ‬
.‫وﻣﻼﺋﻤﺘﻬﺎ ﻟﻸﺣﻤﺎل‬

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 5 of 21
inside the room where the medical device to be
installed, and the proper loads shall be indicated.
5- The concerned manufacturer shall supply the latest ‫ ﻳﺠﺐ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ اﻟﻘﻴﺎم ﺑﺘﻮرﻳﺪ وﺗﻘﺪﻳﻢ اﻷﺣﺪث‬.5
and up-to-date devices/programs/software. This shall ‫وآﺧﺮ ﻣــﺎ ﺗﻢ إﺻــــــــﺪاره )إﻧﺘــﺎﺟــﻪ( ﻣﻦ أﺟﻬﺰة أو ﺑﺮاﻣﺞ وﻫــﺬا‬
apply also to the accessories and relevant hardware ‫ــــــﺎ ﻋﻠﻰ اﻷﺟﻬﺰة اﻟﻤﻠﺤﻘﺔ واﻟﻤﺮﺗﺒﻄﺔ ﺑﺎﻷﺟﻬﺰة‬ ً ‫ﻳﻨﻄﺒﻖ أﻳﻀـ‬
such as the computers and monitors. .‫ﻣﺜﻞ أﺟﻬﺰة اﻟﻜﻤﺒﻴﻮﺗﺮ وﺷﺎﺷﺔ اﻟﻌﺮض‬
6- Devices and relevant accessories/hardware shall be ‫ ﺑﺮﻣﺠﺔ اﻷﺟﻬﺰة وﻣﻠﺤﻘﺎﺗﻬﺎ ورﺑﻄﻬﺎ ﻣﻊ أﺟﻬﺰة أﺧﺮى ﺑﺸـــــﻜﻞ‬.6
programed and connected to the other devices in a .‫ﻣﻨﺎﺳﺐ وﻣﻼﺋﻢ ﻟﺒﻴﺌﺔ اﻟﻌﻤﻞ‬
manner appropriate to the work environment.
7- A device shall be designed in a manner that protect it ‫ﺼــــــﻤﻢ ﺑﺤﻴــﺚ ﻳﻮﻓﺮ ﻟــﻪ اﻟﺤﻤــﺎﻳــﺔ‬
ّ ‫ ﻳﺠــﺐ أن ﻳﻜﻮن اﻟﺠﻬــﺎز ُﻣ‬.7
against the intervention of electromagnetic waves and ‫اﻟﺴـــﻠﻴﻤﺔ ﻣﻦ ﺗﺪﺧﻞ اﻟﻤﻮﺟﺎت اﻟﻜﻬﺮوﻣﻐﻨﺎﻃﻴﺴـــﻴﺔ وﺣﻤﺎﻳﺔ‬
malware (viruses). .‫اﻟﻔﻴﺮوﺳﺎت‬
8- Each item of the relevant medical devices shall be ‫ ﻳ ﺠﺐ أن ﻳﺘﻢ ﺗﻮر ﻳﺪ ﻛﻞ ﺑ ﻨﺪ ﻣﻦ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ ﻋﻦ ﻃﺮﻳﻖ‬.8
supplied by the concerned manufacturer who shall ‫اﻟﺸــﺮﻛﺔ اﻟﺼــﺎﻧﻌﺔ ﻣﻊ ﺗﻘﺪﻳﻢ ﺗﻌﻬﺪ ﺑﺘﻮﻓﻴﺮ اﻟﺼــﻴﺎﻧﺔ وﻗﻄﻊ‬
also submit an undertaking to provide the ‫اﻟﻐﻴﺎر واﻟﻤﺴــــــﺘﻬﻠﻜﺎت ﻟﻤﺪة ﻋﺸــــــﺮ ﺳــــــﻨﻮات ﺑﻌﺪ اﻧﺘﻬﺎء‬
maintenance services, spare parts and consumables ‫ﺗﻮﻗﻒ‬
ّ ‫اﻟﻀﻤﺎن ﻟﻜﻞ ﺑﻨﺪ ﻣﻦ اﻟﺒﻨﻮد وﻻ ﻳﺆﺧﺬ ﺑﻌﻴﻦ اﻹﻋﺘﺒﺎر‬
for ten years following the expiry of warranty period ‫اﻟﻤﺼﻨﻊ ﻋﻦ ﺗﺼﻨﻴﻊ اﻟﺠﻬﺎز وﻳﺠﺐ أن ﻳﺘﻀﻤﻦ اﻟﺘﻌﻬﺪ اﺳﻢ‬
for each item. Factory's suspension of manufacturing ‫اﻟﺠﻬﺎز وﻣﻮدﻳﻠﻪ ورﻗﻤﻪ اﻟﺘﺴــــــﻠﺴــــــﻠﻲ واﺳــــــﻢ اﻟﺸــــــﺮﻛﺔ‬
the same device shall not be taken into account as an ‫ وﻋﻠﻰ اﻟﺸــﺮﻛﺔ اﻟﺼــﺎﻧﻌﺔ ﺗﻘﺪﻳﻢ ﻧﻤﻮذج ﻟﻠﺘﻌﻬﺪ‬،‫اﻟﺼــﺎﻧﻌﺔ‬
excuse for failure to provide such services. The said .‫ﻟﻠﻤﻮاﻓﻘﺔ ﻋﻠﻴﻪ واﻋﺘﻤﺎده واﻟﺘﻤﺸﻲ ﺑﻤﻮﺟﺒﻪ ﺑﻌﺪ ذﻟﻚ‬
undertaking must include the devices name, model,
serial number and manufacturer's name. and the
manufacturer shall submit a form for such
undertaking in order to be approved and adopted as
fixed form thereafter.
Basic Data, Specifications, Power Requirements and ‫ اﻟﻤﻮاﺻـﻔﺎت وﻣﺘﻄﻠﺒﺎت اﻟﻄﺎﻗﺔ‬،‫اﻟﺒﻴﺎﻧﺎت اﻟﺮﺋﻴﺴـﻴﺔ‬
Operation Standards: :‫اﻟﻜﻬﺮﺑﺎﺋﻴﺔ وﻣﻌﺎﻳﻴﺮ اﻟﺘﺸﻐﻴﻞ‬
1. The accepted minimum standards specifications for ‫ﻌﺪات‬ ّ ‫ﻟﻠﻤ‬
ُ ‫ اﻟﺤﺪ اﻷدﻧﻰ ﻟﻠﻤﻮاﺻــــﻔﺎت اﻟﻘﻴﺎﺳــــﻴﺔ اﻟﻤﻘﺒﻮﻟﺔ‬-1
equipment and services shall be IEXC601 (part I and II) ‫ )اﻟﺠﺰء اﻷول واﻟﺜـــﺎﻧﻲ( أو أي‬IEXC601 ‫واﻟﺨـــﺪﻣــﺎت ﻫﻲ‬
or any other similar or higher standard specifications, ،‫ﻣﻮاﺻـــــﻔﺎت ﻗﻴﺎﺳـــــﻴﺔ أﺧﺮى ﻣﺸـــــﺎﺑﻬﻪ ﻟﻬﺎ أو أﻋﻠﻰ ﻣﻨﻬﺎ‬
unless otherwise required. And the same ‫وذﻟـﻚ ﻣـﺎ ﻟﻢ ﻳﻨﺺ ﻋﻠﻰ ﺧﻼف ذﻟـﻚ وﻳﺠـﺐ ﺗـﺪوﻳﻦ ذ ﻟﻚ‬
specifications shall be stated on the relevant devices. .‫ﻋﻠﻰ اﻷﺟﻬﺰة‬
2. Medical devices and their accessories shall be ‫ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ وﻣﻠﺤﻘﺎﺗﻬﺎ ﻳﺠﺐ أن ﺗﺘﻤﺎﺷﻰ ﺑﺸﻜﻞ ﺧﺎص‬-2
specifically in line with the any of the following (IEC601-1, :‫ﻣﻊ أي ﻣﻦ اﻷﻧﻈﻤﺔ اﻟﺪوﻟﻴﺔ اﻟﺘﺎﻟﻴﺔ‬
international systems: (IEC601-1, EN606-1, UL2601-1, EN606-1, UL2601-1, CAS, C2202, No. 60101)
CAS, C2202, No. 60101)
3. The attached specifications shall constitute the ‫ اﻟﻤﻮاﺻﻔﺎت اﻟﻤﺮﻓﻘﺔ ﻫﻲ اﻟﺤﺪ اﻷدﻧﻰ ﻟﻤﺘﻄﻠﺒﺎت ﻣﺠﻠﺲ‬-3
ّ ُ‫اﻟﺼــﺤﺔ وﻋﻠﻰ اﻟﺸــﺮﻛﺔ اﻟﺼــﺎﻧﻌﺔ أن ﺗ‬
minimum requirements of the GCC Health Council, ‫ﻘﺪم اﻷﺟﻬﺰة اﻟﺤﺪﻳﺜﺔ‬
and the manufacturer shall provide the latest devices .(FDA Or CE Or SFDA) ‫اﻟﻤﻄﺎﺑﻘﺔ‬

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 6 of 21
that are compatible with the standards of FDA, CE or
SFDA)
4. All electrical equipment shall be compatible with the ‫ﻌﺪات اﻟﻜﻬﺮﺑﺎﺋﻴﺔ ﻳﺠﺐ أن ﺗﻜﻮن ﻣﺘﻼﺋﻤﺔ ﻣﻊ ﺟﻬﺪ‬
ّ ‫اﻟﻤ‬
ُ ‫ ﺟﻤﻴﻊ‬-4
power supply voltage in the site, and the ‫اﻟﺘﻐﺬﻳﺔ اﻟﻜﻬﺮﺑﺎﺋﻲ ﻓﻲ اﻟﻤﻮﻗﻊ وﻋﻠﻰ اﻟﺸــــﺮﻛﺔ اﻟﺼــــﺎﻧﻌﺔ‬
manufacturer shall ensure that the voltage is (220V (Single ‫( ﻓﻮﻟﺖ وﺟﻪ واﺣﺪ‬220) ‫اﻟﺘﺄﻛﺪ ﻣﻦ ﺟﻬﺪ اﻟﺘﻐﺬﻳﺔ‬
single phase) or (380V three phase) and frequency of ‫( ﻓﻲ اﻟﻤﻮﻗﻊ‬3-phase) ‫ أوﺟﻪ‬3 (‫ ﻓﻮ ﻟﺖ‬380) ‫ أو‬،phase)
50-60 hertz. The same values shall be stated on the ‫ـﺪون ذﻟــﻚ ﻋﻠﻴﻬــﺎ واﻷﺟﻬﺰة اﻟﺘﻲ‬
ّ ‫ ﻫﺮﺗﺰ وأن ﻳـ‬50-60 ‫وﺗﺮدد‬
relevant devices. When the devices require higher ،‫ﺗﺘﻄﻠﺐ ﺟﻬﺪ أﻋﻠﻰ ﻳﺠﺐ ﺗﻮﺿﻴﺢ ذﻟﻚ ﻋﻠﻴﻬﺎ ﺑﺸﻜﻞ واﺿﺢ‬
voltage, the same shall be expressly indicated. All ‫ﺤﻮل ﻛﻤﺎ ﻳﺠﺐ‬
ّ ‫وﺳــــــﻴﺘﻢ رﻓﺾ أي ﺟﻬﺎز ﻳﻌﻤﻞ ﻋﻦ ﻃﺮﻳﻖ ُﻣ‬
devices which need adapters will be rejected. All ‫( ﻫﺮﺗﺰ‬50-60) ‫اﻟﻤﻌـ ّـﺪات ﺗﻌﻤــﻞ ﻋﻠﻰ ﺗﺮدد‬
ُ ‫أن ﺗﻜﻮن ﺟﻤﻴﻊ‬
devices must be compatible with the 50-60 hertz ‫ﺣﺴـــــــﺐ ﺗﺮدد ﻛﻞ دوﻟﺔ ﻣﻦ دول ﻣﺠﻠﺲ اﻟﺘﻌﺎون اﻟﺨﻠﻴﺠﻲ‬
frequency and according to the frequencies applicable ‫وﺳـــــﻴﺘﻢ رﻓﺾ أي أﺟﻬﺰة ﻻ ﺗﺘﻮاﻓﻖ ﻣﻊ ﺗﺮدد ﻛﻞ دوﻟﺔ ﻣﻦ‬
in each of the GCC countries, and non-complaint .‫دول اﻟﻤﺠﻠﺲ‬
devices will be rejected.
5. External power regulators or adapter or similar ‫ﺤﻮﻻت أو‬ ّ ‫ ﻻ ُﻳﺴﻤﺢ ﺑﺎﺳﺘﺨﺪام ُﻣﻨﻈﻤﺎت ﻃﺎﻗﺔ ﺧﺎرﺟﻴﺔ أو ُﻣ‬-5
ً
equipment shall not be allowed except if accepted in ‫ﻣﺴــــــﺒﻘﺎ ﻣﻦ ﻗﺒﻞ‬ ‫ﻣﺎ ﻳﻤﺎﺛﻠﻬﺎ إﻻ إذا ﺗﻤﺖ اﻟﻤﻮاﻓﻘﺔ ﻋﻠﻴﻬﺎ‬
advance by the Member States and Participating ‫اﻟﺪول اﻷﻋﻀــــﺎء واﻟﺠﻬﺎت اﻟﻤﺸــــﺎرﻛﺔ إذا ﺗﻢ ﻗﺒﻮل أي ﻣﻦ‬
Parties. If such adapters are accepted they must be ‫اﻟﻤﺤﻮﻻت ﺑﺸــــﺮط أن ﺗﻜﻮن ﻣﺼــــﻨّ ﻔﺔ ﻟﻼﺳــــﺘﺨﺪام اﻟﻄﺒﻲ‬
ّ
classified among the applications approved for .‫اﻟﻤﺮاﻛﺰ اﻟﻄﺒﻴﺔ‬/‫داﺧﻞ اﻟﻤﺴﺘﺸﻔﻴﺎت‬
medical usage inside hospitals/medical centers.
6. Electrical plugs for the relevant device must be ‫اﻟﻤﺴــــــﺘﺨﺪﻣﺔ ﻳﺠﺐ أن ﺗﻜﻮن‬
ُ ‫ اﻟﻤﻘﺎﺑﺲ اﻟﻜﻬﺮﺑﺎﺋﻴﺔ ﻟﻸﺟﻬﺰة‬-6
classified as acceptable for medical usage inside ‫ﻣﺼـــﻨّ ﻔﺔ ﻟﻼﺳـــﺘﺨﺪام اﻟﻄﺒﻲ داﺧﻞ ﻣﺴـــﺘﺸـــﻔﻴﺎت اﻟﺪول‬
hospitals of the Member States and Participating ‫اﻷﻋﻀــــــﺎء واﻟﺠﻬﺎت اﻟﻤﺸــــــﺎرﻛﺔ وﻳﺘﻄﻠﺐ ﺗﺄﻣﻴﻦ اﻟﻤﻘﺎﺑﺲ‬
Parties. It is required that the appropriate plugs be (Hospital Grade System) ‫اﻟﺼﺤﻴﺤﺔ ﻣﻊ اﻟﺠﻬﺎز‬
provided with the devices (hospital grade system).
Tests: :‫اﻻﺧﺘﺒﺎرات‬
1- The concerned manufacturer shall coordinate with ‫ ﻳﺠﺐ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ أن ﺗﻘﻮم ﺑﺎﻟﺘﻨﺴﻴﻖ ﻣﻊ ﻣﻤﺜﻞ‬.1
the representative of the relevant Engineering Dept. ‫اﻹدارة اﻟﻬ ﻨﺪﺳــــــﻴﺔ اﻟﻤﻌﻨ ﻴﺔ ﺑﺎ ﻟﺪول اﻷﻋﻀـــــــﺎء واﻟﺠﻬﺎت‬
in the Member States and Participating Parties on ‫اﻟﻤ ﺸﺎرﻛﺔ ﻓﻲ اﻟﻮﻗﺖ اﻟﻤﻨﺎ ﺳﺐ ﻟﻪ ﺑﺈﺟﺮاء اﺧﺘﺒﺎر ﺗ ﺸﻐﻴﻠﻲ‬
proper time in order to perform a full operation test ‫ﻛﺎﻣﻞ )ﻗﺒﻞ اﻋﺘﻤﺎد ﺗﺸـﻐﻴﻞ اﻟﺠﻬﺎز ﻟﺠﻤﻴﻊ اﻟﺘﺮﻛﻴﺒﺎت ﺑﺄﻛﻤﻠﻬﺎ‬
(before approving the operation of the device with all ‫ وﻻ ﻳﺘﻢ اﺳــــــﺘﻼم اﻷﺟﻬﺰة إﻻ‬،(‫ﻋﻨﺪ اﻻﻧﺘﻬﺎء ﻣﻦ اﻷﻋﻤﺎل‬
installations after finishing the works); no devices will ‫ﺑﻌﺪ إﺟﺮاء اﺧﺘﺒﺎرات اﻟﻘﺒﻮل اﻟﻼزﻣﺔ وﺑﺤﻀـــــﻮر ﻣﻬﻨﺪﺳـــــﻴﻦ‬
be received except after performing the required ‫ﻣﻦ اﻹدارة اﻟﻬﻨﺪﺳــــﻴﺔ ﻣﻊ ﺗﻘﺪﻳﻢ اﻟﻮﺛﺎﺋﻖ اﻟﺮﺳــــﻤﻴﺔ ﻟﺬﻟﻚ‬
Acceptance Tests in the presence of engineers from ‫ﻋﻠﻰ أن ﺗﺸﻤﻞ ﺟﻤﻴﻊ اﻻﺧﺘﺒﺎرات اﻟﻀﺮورﻳﺔ ﺣﺴﺐ اﻟﻤﻌﺎﻳﻴﺮ‬
the relevant Dept. , and the official documentation of .‫اﻟﻌﺎﻟﻤﻴﺔ‬
the process shall be submitted, provided that they
must include all necessary tests and according to the
international standards.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 7 of 21
2- A device shall not be considered out of the warranty ‫ ﻻ ﻳﺘﻢ اﻋﺘﺒﺎر اﻟﺠﻬﺎز ﺧﺎرج ﻓﺘﺮة اﻟﻀــــﻤﺎن إﻻ ﺑﻌﺪ اﺳــــﺘﻜﻤﺎل‬.2
period except after completion of all official ‫ﻛﺎﻓﺔ اﻹﺟﺮاءات اﻟﻨﻈﺎﻣﻴﺔ اﻟﺨﺎﺻـــــــﺔ ﺑﻤﺤﻀــــــﺮ اﻻﺳــــــﺘﻼم‬
procedures in the Final Receipt Minutes which needs ‫اﻟﻨﻬﺎﺋﻲ واﻋﺘﻤﺎده ﻣﻦ إدارات اﻟﺼــــــﻴﺎﻧﺔ ﺑﺎﻟﺪول اﻷﻋﻀــــــﺎء‬
to be approved by the concerned Maintenance .‫واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ‬
Departments in the Member States and Participating
Parties.
Training: :‫اﻟﺘﺪرﻳﺐ‬
1. A program for training of doctors and engineers on the ‫ ﻳﺠﺐ ﺗﻘﺪﻳﻢ ﺑﺮﻧﺎﻣﺞ ﻟﺘﺪرﻳﺐ اﻷﻃﺒﺎء واﻟﻤﻬﻨﺪﺳـــﻴﻦ ﺣﺴـــﺐ‬-1
operation of devices must be provided by the ،‫ﺗﺪرﻳﺐ اﻟﺸــــــﺮﻛﺔ اﻟﺼــــــﺎﻧﻌﺔ ﻟﻸﺟﻬﺰة اﻟﻤﺸــــــﻤﻮﻟﺔ ﺑﺎﻟﻌﻘﺪ‬
manufacturer for all devices covered by the contract. ‫وﺳــــــﻮف ﻳﻜﻮن ﻫﺬا اﻟﺒﺮﻧﺎﻣﺞ ﻣﻦ اﻟﻨ ﻘﺎط اﻷﺳـــــــﺎﺳــــــﻴﺔ‬
This training program shall be considered as major .‫ﻟﻠﻤﻔﺎﺿﻠﺔ ﺑﻴﻦ ﻋﺮوض اﻟﺸﺮﻛﺎت اﻟﻤﺘﻨﺎﻓﺴﺔ‬
points of preference between competing companies.
2. All doctors, technicians and staffs will be trained on ‫ ﺗــﺪرﻳــﺐ اﻷﻃﺒــﺎء واﻟﻔﻨﻴﻴﻦ وﺟﻤﻴﻊ اﻟﻌــﺎﻣﻠﻴﻦ ﻋﻠﻰ اﻟﺠﻬــﺎز‬-2
the safe and efficient operation of the device as well ‫واﻟﻔﻌﺎل وﺟﻤﻴﻊ اﻟﺘﻄﺒﻴﻘﺎت‬
ّ ‫ﻋﻠﻰ ﻃﺮﻳﻘﺔ اﻟﺘﺸــــﻐﻴﻞ اﻵﻣﻦ‬
as all applications which ensure the full advantage of ‫واﻹﻣﻜﺎﻧﺎت اﻟﺘﻲ ﻳﺘ ﻀﻤﻦ اﻻ ﺳﺘﻔﺎدة ﻣﻦ اﻟﺠﻬﺎز وﻳﺠﺐ أن‬
the device. Such training must be provided by ‫ﻳﺘﻢ ذﻟﻚ ﺑﻮاﺳــﻄﺔ ﻣﺘﺨﺼــﺼــﻴﻦ وﻋﻠﻰ اﻟﺸــﺮﻛﺔ اﻟﺼــﺎﻧﻌﺔ‬
specialized personnel and the company must provide .‫إﺑﺮاز ﻣﺎ ﻳﺜﺒﺖ ﻗﻴﺎﻣﻬﺎ ﺑﺬﻟﻚ‬
proof on provision of the same.
3. Maintenance engineers and technicians at the ‫ ﺗــﺪرﻳــﺐ ﻣﻬﻨــﺪﺳــــــﻲ وﻓﻨﻴﻲ اﻟﺼــــــﻴــﺎﻧــﺔ اﻟﻌــﺎﻣﻠﻴﻦ ﻓﻲ‬-3
relevant hospital must be trained on the methods of ‫اﻟﺪورﻳﺔ واﻟﻮﻗﺎﺋﻴﺔ‬
ّ ‫اﻟﻤﺴــــــﺘﺸــــــﻔﻰ ﻋﻠﻰ ﻃﺮق اﻟﺼــــــﻴﺎﻧﺔ‬
regular and preventive maintenance and emergency ‫وإﺻﻼح اﻷﻋﻄﺎل اﻟﻄﺎرﺋﺔ ﺑﺼﻮرة ﻋﺎﻣﺔ وﻛﺬﻟﻚ ﻋﻠﻰ ﻛﻴﻔﻴﺔ‬
troubleshooting in general, and on how to use, ‫اﻻﺳﺘﺨﺪام واﻟﻌﻨﺎﻳﺔ وإﻋﺎدة اﻟﻀﺒﻂ وﻣﻌﺎﻟﺠﺔ اﻟﺠﻬﺎز وﻳﺠﺐ‬
maintain, reset and deal with the device. This training ‫أن ﻳﺘﻢ ذﻟﻚ اﻟﺘﺪرﻳﺐ ﻗﺒﻞ اﻟﺘﺸـــﻐﻴﻞ اﻟﻤﺘﻮﻗﻊ ﻟﻠﺠﻬﺎز ﻷول‬
shall be provided before the first running of the device ‫ﻣﺮة وﻋﻨﺪ اﻟﻀــــــﺮورة وﻋﻠﻰ اﻟﺸــــــﺮﻛﺔ اﻟﺼــــــﺎﻧﻌﺔ أن ﺗﺆﻣﻦ‬
ّ
and when required; the manufacturer shall provide to ‫ﻟﻠﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ دون أي ﺗﻜﻠﻔﺔ ﻟﻠﺘﺪرﻳﺐ‬
the Member States and Participating Party the ‫اﻟﻤﻜﻤﻞ ﺧﻼل ﻓﺘﺮة اﻟﻀــﻤﺎن وذﻟﻚ ﺑﻮاﺳــﻄﺔ ﻣﺘﺨﺼــﺼــﻴﻦ‬
ّ
complementary training (free of charge) during the ‫وﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺗﻘﺪﻳﻢ ﻣﺎ ﻳﺜﺒﺖ ﻗﻴﺎﻣﻬﺎ ﺑﺬﻟﻚ وأﻻ‬
warranty period through specialized personnel, and ‫ أﻳــﺎم ﻋﻤــﻞ( وذﻟــﻚ ﻟﻸﺟﻬﺰة‬10) ‫ﺗﻘــﻞ ﻣــﺪة اﻟﺘــﺪرﻳــﺐ ﻋﻦ‬
the manufacturer shall submit a proof on providing .‫اﻟﻤﺘﻘﺪﻣﺔ‬
ّ ‫اﻟﺘﺨﺼﺼﻴﺔ‬
ّ ‫ ﻳﻮم ﻋﻤﻞ( ﻟﻸﺟﻬﺰة‬25)‫ و‬،‫اﻟﻌﺎدﻳﺔ‬
the same. Training period shall be no less than ten (10)
days for the normal devices, and twenty five (25) days
for advanced devices.
4. The manufacturer shall provide the CVs for the ‫ ﻳﺠﺐ ﻋﻠﻰ اﻟﺸــــــﺮﻛﺔ اﻟﺼـــــــﺎﻧﻌﺔ ﺗﻘﺪﻳﻢ اﻟﺴــــــﻴﺮة اﻟﺬاﺗﻴﺔ‬-4
specialized personnel who will provide training for ‫ﻟﻠﻤﺘﺨﺼﺼﻴﻦ اﻟﺬﻳﻦ ﺳﻴﻘﻮﻣﻮن ﺑﺘﺪرﻳﺐ اﻷﻃﺒﺎء واﻟﻔﻨﻴﻴﻦ‬
doctors and technicians in order to be approved by the ‫ﻟﻴﺘﻢ اﻋﺘﻤﺎدﻫﻢ ﻣﻦ ﻗ ﺒﻞ إدارة ﺧﺪﻣﺎت اﻷﺷــــــﻌﺔ ﺑﺎﻟﺪول‬
Department of Radiology Services in the Member ‫اﻷﻋﻀـــﺎء واﻟﺠﻬﺎت اﻟﻤﺸـــﺎرﻛﺔ وذﻟﻚ ﻟﻸﺟﻬﺰة اﻟﺘﺨﺼـــﺼـــﻴﺔ‬
States and Participating Parties. This applies to the .‫اﻟﻤﺘﻘﺪﻣﺔ‬
ّ
advanced medical devices.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 8 of 21
5. After completion of training courses, a statement ‫ ﻳﺠــﺐ ﺗﻘــﺪﻳﻢ ﺑﻴــﺎن ﺑــﺄﺳــــــﻤــﺎء‬،‫ ﺑﻌــﺪ اﻻﻧﺘﻬــﺎء ﻣﻦ اﻟﺘــﺪرﻳـﺐ‬-5
containing the names of doctors, engineers and ‫اﻟﻤﺘﺪرﺑﻴﻦ ﻣﻦ أﻃﺒﺎء وﻣﻬﻨﺪﺳـــﻴﻦ وﻓﻨﻴﻴﻦ وﻏﻴﺮه وﻳﺠﺐ أن‬
technicians who were trained shall be submitted. The ‫ﻳﺘﻀﻤﻦ اﻟﺘﺪرﻳﺐ ﺗﻘﻴﻴﻢ ﻋﻤﻠﻲ وﻧﻈﺮي ﻟﻤﺴﺘﺨﺪﻣﻲ اﻟﺠﻬﺎز‬
training statement shall include a practical and ‫ﻣﻦ أﻃﺒـــﺎء وﻓﻨﻴﻴﻦ ﻋﻠﻰ أن ﻳﻘـــﺪم ﻓﻲ ﻧﻬـــﺎﻳـــﺔ اﻟﺘﻘﻴﻴﻢ‬
theoretical assessment of the users of the devices .‫ﺷﻬﺎدة ﻟﻠﻤﺠﺘﺎزﻳﻦ ﺗﻔﻴﺪ ﺑﻘﺪرﺗﻬﻢ ﻋﻠﻰ اﺳﺘﺨﺪام اﻟﺠﻬﺎز‬
(doctors and technicians) , provided that a certificate
to evidence the trainees ability to use the device must
be provided at the end of training course.
6. Manufacturer shall provide the education means ‫ ﻋﻠﻰ اﻟﺸــــــﺮ ﻛﺔ اﻟﺼـــــــﺎﻧ ﻌﺔ ﺗ ﻘﺪﻳﻢ اﻟﻮﺳـــــــﺎ ﺋﻞ اﻟﺘﻌﻠﻴﻤ ﻴﺔ‬-6
available at the company such as remote training … .‫اﻟﻤﺘﻮﻓﺮة ﻟﺪى اﻟﺸﺮﻛﺔ ﻣﺜﻞ اﻟﺘﺪرﻳﺐ ﻋﻦ ﺑﻌﺪ‬
etc.
7. In case a device is upgraded to raise its efficiency, ‫ ﻓﻲ ﺣﺎل ﺗﺮﻗﻴﺔ اﻟﺠﻬﺎز ﻟﺮﻓﻊ ﻣﺴــــﺘﻮى ﻛﻔﺎءﺗﻪ ﺳــــﻮاء ﻛﺎﻧﺖ‬-7
whether by addition of new equipment or updating ‫ﻫﺬه اﻟﺘﺮﻗﻴﺔ ﺑﺈﺿﺎﻓﺔ ﻣﻼﺣﻖ ﻟﻠﺠﻬﺎز أو ﺗﺮﻗﻴﺔ ﺑﺮاﻣﺠﻪ وﻛﺎﻧﺖ‬
the software, and such upgrade needed additional ‫ﻫﺬه اﻟﺘﺮﻗﻴﺔ ﺗﺘﻄﻠﺐ ﺗﺪرﻳﺐ إﺿـــــــﺎﻓﻲ ﻓﺈﻧﻪ ﻳﺠﺐ ﺗﻘﺪﻳﻢ‬
training, then the manufacturer shall provide ‫ﺗﺪرﻳﺐ إﺿﺎﻓﻲ وإﻟﺤﺎﻗﻲ ﻳﻘﺪم ﻣﻦ ﻗﺒﻞ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ‬
additional and complementary training (free of .‫وﺑﺪون ﺗﻜﺎﻟﻴﻒ وذﻟﻚ ﻟﻌﻤﻞ اﻟﺠﻬﺎز وﺗﺸﻐﻴﻠﻪ‬
charge) on how to operate the relevant device.
8. Preventive maintenance schedule and visits during the .‫ ﺑﺮﻧﺎﻣﺞ اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ واﻟﺰﻳﺎرات ﺧﻼل ﻓﺘﺮة اﻟﻀﻤﺎن‬-8
warranty period shall be provided.
• In case a device encountered malfunction during the ‫ﺗﻌﻄﻞ اﻟﺠﻬﺎز ﺧﻼل ﻓﺘﺮة اﻟﻀﻤﺎن واﻻﺣﺘﻴﺎج ﻟﻨﻘﻠﻪ‬
ّ ‫ﻓﻲ ﺣﺎل‬ •
warranty period and there was a need to move it ‫ﺧﺎرج اﻟﻤﺴــــﺘﺸــــﻔﻰ ﻟﻺﺻــــﻼح ﺗﺘﻜﻔﻞ اﻟﺸــــﺮﻛﺔ اﻟﺼــــﺎﻧﻌﺔ‬
ً ‫ﺑﺘــﺄﻣﻴﻦ ﺟﻬــﺎز ﺑــﺪﻳــﻞ ﺧﻼل ﻓﺘﺮة اﻹﺻــــــﻼح ﺣﺮﺻـ‬
outside the hospital for repair service, the ‫ـــــــﺎ ﻋﻠﻰ‬
manufacturer shall provide an alternative device .‫ﻘﺪﻣﺔ‬
ّ ‫اﻟﻤ‬
ُ ‫اﺳﺘﻤﺮارﻳﺔ اﻟﺨﺪﻣﺔ‬
throughout the repair period so as the maintain the
continuity of the provided service.
Fines of default in maintenance service during the :‫ﻏﺮاﻣﺎت اﻟﺘﻘﺼﻴﺮ ﻓﻲ اﻟﺼﻴﺎﻧﺔ ﺧﻼل ﻓﺘﺮة اﻟﻀﻤﺎن‬
warranty period:
When the manufacturer delays the finishing of ‫ﻋﻨﺪﻣﺎ ﺗﺘﺄﺧﺮ اﻟﺸـــﺮﻛﺔ اﻟﺼـــﺎﻧﻌﺔ ﻓﻲ إﻧﻬﺎء أو اﺳـــﺘﻜﻤﺎل إﺻـــﻼح‬
troubleshooting for any medical device or fails to perform ‫ﺤﺪد أو اﻟﺘﻘﺼــــﻴﺮ ﻓﻲ‬
ّ ‫اﻟﻤ‬
ُ ‫اﻷﻋﻄﺎل ﻷي ﺟﻬﺎز ﻃﺒﻲ ﻓﻲ اﻟﻮﻗﺖ‬
the periodical maintenance works, then the manufacturer ‫اﻟﻘﻴﺎم ﺑﺄﻋﻤﺎل اﻟﺼـــــﻴﺎﻧﺔ اﻟﺪورﻳﺔ ﻓﺴـــــﻴﺘﻌﺮض ﻟﺘﻮﻗﻴﻊ ﺣﺴـــــﻢ‬
shall be subject to a delay or failure penalty. :‫ﻏﺮاﻣﺎت اﻟﺘﺄﺧﻴﺮ أو اﻟﺘﻘﺼﻴﺮ‬

Schedule of Maintenance Failure or Delay Fines during the ‫ﺟﺪول ﻏﺮاﻣﺎت اﻟﺘﻘﺼـــــﻴﺮ ﻓﻲ اﻟﺼـــــﻴﺎﻧﺔ ﺧﻼل ﻓﺘﺮة‬
Warranty Period: ‫اﻟﻀﻤﺎن‬

# Medical Repair Delay fine for one Fine of Delay in ‫ﻏﺮاﻣﺔ اﻟﺘﻘﺼـــــــﻴﺮ ﻓﻲ‬ ‫ﻏﺮاﻣــﺔ ﺗــﺄﺧﻴﺮ اﻹﺻـــــــﻼح ﻓﻲ‬ ‫ﻓــﺌــــﺔ ﺗﺼــــــــﻨــﻴــﻒ‬ ‫م‬

Device day per device Schedule ‫أﻋــﻤــــﺎل اﻟﺼـــــــــﻴــــﺎﻧـــﺔ‬ ‫اﻟﻴﻮم اﻟﻮاﺣﺪ ﻟﻠﺠﻬﺎز اﻟﻮاﺣﺪ‬ ‫اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬

Class preventive ‫اﻟﻤﺠـــﺪوﻟـــﺔ‬


ُ ‫اﻟﻮﻗـــﺎﺋﻴـــﺔ‬

Maintenance

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 9 of 21
‫‪Works for one day‬‬ ‫ﻓــﻲ اﻟــﻴــﻮم اﻟــﻮاﺣـــﺪ‬

‫‪per device‬‬ ‫ﻟﻠﺠﻬﺎز اﻟﻮاﺣﺪ‬

‫‪1‬‬ ‫‪CT‬‬ ‫‪and‬‬ ‫‪800 USD, with an obligation‬‬ ‫‪50 USD‬‬ ‫)‪ (50‬ﻓﻘﻂ ﺧﻤﺴــــــﻮن‬ ‫)‪ (800‬ﻓﻘﻂ ﺛﻤــﺎﻧﻤــﺎﺋــﺔ دوﻻر‬ ‫اﻷﺷـــــــــــــــــــﻌــــــــــــﺔ‬ ‫‪1‬‬
‫ﻻ ﻏﻴﺮ‬
‫‪MRI‬‬ ‫‪on the manufacturer to‬‬ ‫دوﻻر ﻻ ﻏﻴﺮ‬ ‫اﻟﻤﻘﻄﻌﻴﺔ واﻟﺮﻧﻴﻦ‬
‫ﻣﻊ اﻻﻟﺘﺰام ﺑﺈرﺳﺎل اﻟﻤﺮﺿﻰ‬
‫‪refer patients to private‬‬ ‫اﻟﻤﻐﻨﺎﻃﻴﺴﻲ‬
‫اﻟﺨﺎﺻ ـﺔ‬
‫ّ‬ ‫إﻟﻰ اﻟﻤﺴــﺘﺸــﻔﻴﺎت‬
‫‪hospitals at the company's‬‬
‫وﻋﻠﻰ ﺣﺴــــــــــﺎب اﻟﺸـــــــﺮﻛـــﺔ‬
‫‪expense and the cost shall‬‬
‫ً‬
‫وﺣﺴﻤﺎ ﻣﻦ ﻣﺴﺘﺤﻘﺎﺗﻬﺎ‬
‫‪be deducted from its dues.‬‬
‫)‪ (50‬ﻓﻘﻂ ﺧﻤﺴــــــﻮن‬ ‫)‪ (130‬ﻓﻘﻂ ﻣـــﺎﺋـــﺔ وﺛﻼﺛﻮن‬ ‫أي ﺟﻬﺎز آﺧﺮ‬ ‫‪2‬‬
‫‪2‬‬ ‫‪Any‬‬ ‫‪130 USD‬‬ ‫‪50 USD‬‬
‫دوﻻر ﻻ ﻏﻴﺮ‬
‫دوﻻر ﻻ ﻏﻴﺮ‬
‫‪other‬‬
‫‪device‬‬

‫ﺗﻠﺘﺰم اﻟﺸـﺮﻛﺔ اﻟﺼـﺎﻧﻌﺔ ﺑﻀـﻤﺎن ﺟﻤﻴﻊ اﻷﺟﺰاء واﻟﻤﻮاد ‪A) The manufacturer shall provide warranty for all parts‬‬ ‫أ(‬
‫واﻟﻘﻄﻊ اﻟﺨﺎﺻﺔ ﺑﺎﻟﺠﻬﺎز واﻟﺘﻲ ﻟﻢ ﺗُ ﺬﻛﺮ ﺿﻤﻦ اﻟﺠﺪول ‪and materials of the relevant device which were not‬‬
‫ﻃﻮال ﻓﺘﺮة اﻟﻀــــــﻤﺎن وﻓﻲ ﺣﺎﻟﺔ اﻟﺤﺎﺟﺔ ﻟﺘﻐﻴﻴﺮﻫﺎ أو ‪mentioned in the schedule. In case a device part is‬‬
‫‪damaged‬‬ ‫‪and‬‬ ‫‪needs‬‬ ‫‪to‬‬ ‫‪be‬‬ ‫‪changed,‬‬ ‫ﺗﻠﻔﻬﺎ ﺗﻠﺘﺰم اﻟﺸــﺮﻛﺔ اﻟﺼــﺎﻧﻌﺔ ﺑﺘﻐﻴﻴﺮﻫﺎ ﻣﻬﻤﺎ ﺑﻠﻎ ﻋﺪد ‪the‬‬
‫‪manufacturer shall change the same (no matter how‬‬ ‫ﻣﺮات ﺗﻐﻴﻴﺮﻫﺎ ﺧﻼل ﻓﺘﺮة اﻟﻀﻤﺎن‪.‬‬
‫‪many times) during the warranty period.‬‬ ‫اﻟﻌﻄﻞ ﺑﺨﻄﺎب‬
‫ب( ﺗﺤﺴــــــﺐ اﻟﻐﺮاﻣﺔ ﻣﻦ ﺗﺎرﻳﺦ اﻟﺘﺒﻠﻴﻎ ﻋﻦ ُ‬
‫ﻮﺟﻪ ﻣﻦ اﻟﺪول اﻷﻋﻀـــﺎء واﻟﺠﻬﺎت اﻟﻤﺸـــﺎرﻛﺔ أو ﻋﻦ‬
‫ُﻣ ّ‬
‫ﻃﺮﻳﻖ اﻟﺒﺮﻳـــﺪ اﻹﻟﻜﺘﺮوﻧﻲ‪ ،‬وإذا زادت ﻣـــﺪة إﺻــــــﻼح ‪B) Fine shall accrue from the date of notifying the‬‬
‫اﻟﺠﻬﺎز ﻋﻦ ﺛﻼﺛﺔ أﻳﺎم إﻟﻰ أن ﻳﺘﻢ إﺻــــﻼح اﻟﺠﻬﺎز ﻣﻬﻤﺎ ‪manufacturer of the fault through a letter or email‬‬
‫ﺑﻠﻐــﺖ ُﻣ ـﺪة اﻟﻌﻄــﻞ أو ﻓﻲ ﺣــﺎﻟــﺔ اﻟﺘــﺄﺧﻴﺮ ﻓﻲ ﺗﻨﻔﻴــﺬ ‪addressed by the Member State or Participating‬‬
‫أﻋﻤــﺎل اﻟﺼــــــﻴــﺎﻧــﺔ اﻟﻮﻗــﺎﺋﻴــﺔ ﻟﻠﺠﻬــﺎز‪ ،‬ﺗﻄﺒﻖ اﻟﻐﺮاﻣــﺎت ‪Party, and if the repair period exceeded three days,‬‬
‫‪the fine shall be imposed until the actual fixing of the‬‬ ‫اﻟﻤﻨﺼﻮص ﻋﻠﻴﻬﺎ ﺑﺎﻟﺠﺪول اﻟﺴﺎﺑﻖ‪.‬‬
‫ج( ﻓﻲ ﺣــﺎﻟــﺔ ﻋــﺪم ﺗﻘــﺪﻳﻢ اﻟﺘﻘﺮﻳﺮ اﻟﻤــﺬﻛﻮر ﻓﻲ اﻟﻤﻮﻋــﺪ ‪device. In case of delay in performing preventive‬‬
‫اﻟﻤﻮﺿـــﺢ وﺑﻤﺒﺮرات ﻣﻘﺒﻮﻟﺔ ﻓﺈن ذﻟﻚ ﻳﻌﻨﻲ اﻟﻔﺸـــﻞ ‪maintenance works for the device, the fines‬‬
‫ُ‬
‫ﻓﻲ إﻧﺠﺎز اﻹﺻــﻼح وﻋﻨﺪﻫﺎ ﺳــﺘﻘﻮم اﻟﺠﻬﺔ اﻟﻤﺸــﺎرﻛﺔ ‪provided for in the aforementioned schedule shall‬‬
‫‪be applied.‬‬ ‫ً‬
‫وﻓﻮرا ﺑﺘﻌﻤﻴـــﺪ ﻣﻦ ﺗﺮاه‬ ‫ﻣﻤﺜﻠـــﺔ ﻓﻲ إدارة اﻟﻤﻮﻗﻊ‬
‫ﻣﻨﺎﺳﺒﺎ ﻹﺻﻼح اﻷﻋﻄﺎل ﻷي ﺟﻬﺎز وذﻟﻚ ﻋﻠﻰ ﺣﺴﺎب ‪C) If the said report was not provided within the‬‬ ‫ً‬
‫ً‬
‫وﺣﺴــــﻤﺎ ﻣﻦ أي ﻣﻄﺎﻟﺐ ﻟﺼــــﺮف ‪specified time limit and with the acceptable‬‬ ‫اﻟﺸــــﺮﻛﺔ اﻟﺼــــﺎﻧﻌﺔ‬
‫‪justifications, then this shall mean that the‬‬ ‫ً‬
‫وﻓﻘﺎ ﻟﻤﺎ ﻳﻠﻲ‪:‬‬ ‫اﺳﺘﺤﻘﺎﻗﻬﺎ وﻳﺘﻢ ﺗﻮﻗﻴﻊ اﻟﺤﺴﻢ‬
‫ج‪ (1-‬ﺣﺴــــــﻢ أﺟﻮر اﻟﺨــﺪﻣـﺔ واﻹﺻــــــﻼح ﻣﻬﻤــﺎ ﺑﻠﻐـﺖ ‪manufacturer failed to complete the repair works in‬‬
‫اﻟﺘﻜﺎﻟﻴﻒ وﺑﺪون ﺣﺪ أﻗﺼﻰ ﺣﻴﺚ أن اﻟﺤﺴﻢ ﻓﻲ ﻫﺬه ‪which case the Participating Party as represented by‬‬
‫اﻟ ﺤﺎ ﻟﺔ ﻳﻜﻮن )ﻛﻤ ﻘﺎ ﺑﻞ( وﻻ ﻳﺪ ﺧﻞ ﺿــــــﻤﻦ أﻗﺼــــــﻰ ‪the site management shall assign a proper company‬‬
‫‪to have the device repaired at the expense of the‬‬ ‫اﻟﻌﻘﻮﺑﺎت‪.‬‬
‫ج‪ (2-‬ﻻ ﻳﺨﻞ ﻣﺎ ﺗﻮﺿـــــﺢ ﻓﻲ اﻟﻔﻘﺮة اﻟﺴـــــﺎﺑﻘﺔ ﺑﺘﻮﻗﻊ ‪manufacturer and the costs shall be deducted from‬‬
‫‪any dues outstanding for the manufacturer. The‬‬ ‫اﻟﻐﺮاﻣﺎت اﻷﺧﺮى اﻟﺘﻲ ﺗﻮﺿﺢ ﺑﻴﺎﻧﻬﺎ‪.‬‬
‫‪deduction fine shall be imposed as follows:‬‬
‫‪C-1) The service and repair costs shall be deducted‬‬
‫‪no matter how much the amount, and in this case‬‬

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


‫‪Special Conditions & Terms of Supply for Tender of Medical Devices‬‬
‫‪Page 10 of 21‬‬
the deduction shall be considered as (fees) not as
remedy.

C-2) The provisions of the aforementioned


paragraph shall not prejudice the imposition of other
prescribed penalties.
Manufacturer shall replace any required spare parts with ‫ﺗﻠﺘﺰم اﻟﺸـــــﺮﻛﺔ اﻟﺼـــــﺎﻧﻌﺔ ﺑﺘﺒﺪﻳﻞ أي ﻗﻄﻊ ﻏﻴﺎر ﻣﻄﻠﻮﺑﺔ ﺑﻘﻄﻊ‬
other original/new parts made by the original ‫أ ﺻﻠﻴﺔ وﺟﺪﻳﺪة ﻣﻦ ﻗﺒﻞ ﻣ ﺼﻨّ ﻊ اﻷﺟﻬﺰة اﻷ ﺻﻠﻲ ﻋﻠﻰ أن ﻳﺘﻢ‬
manufacturer, provided that the same must be first ،‫اﻋﺘﻤﺎدﻫﺎ ﻣﻦ ﻗﺒﻞ اﻷﻗﺴﺎم اﻟﻬﻨﺪﺳﻴﺔ ﻓﻲ اﻟﻤﻨﺸﺂت اﻟﻄﺒﻴﺔ‬
approved by the Engineering Depts. in the medical ‫ﺗﻮﻓﺮ ﻗﻄﻊ اﻟﻐﻴﺎر ﻟﻐﺮض اﻹﺻﻼح ﺧﻼل أﺳﺒﻮع‬
ّ ‫وﻓﻲ ﺣﺎل ﻋﺪم‬
institutions. In case the spare parts are not provided for ‫ وﺗﺰاد‬،‫ ﻣﻦ ﻗﻴﻤﺔ ﻣﺎ ﺗﺄﺧﺮ ﻓﻲ ﺗﻨﻔﻴﺬه‬%5 ‫ﻳﺨﺼــــــﻢ ﻣﺎ ﻧﺴــــــﺒﺘﻪ‬
repair purposes within one week, 5% of the value of ‫ ﻣﻦ ﻗﻴﻤﺔ ﺗﻠﻚ اﻷﻋﻤﺎل‬%10 ‫اﻟﻨﺴﺒﺔ ﻟﺘﺼﻞ إﻟﻰ‬
delayed works shall be deducted, and this percentage may
be increased to 10% of the value of those works.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 11 of 21
Supply Conditions for Medical
‫ﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬
Devices Tender
• Awarded manufacturer shall supply the devices in boxes ‫ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ اﻟﺘﻲ ﺗﻤﺖ اﻟﺘﺮﺳﻴﺔ ﻋﻠﻴﻬﺎ ﺗﻮرﻳﺪ اﻷﺟﻬﺰة ﻓﻲ‬
sealed at the registered factory. Marks shall be placed ‫ﺻﻨﺎدﻳﻖ ﻣﻐﻠﻘﺔ ﻣﻦ اﻟﻤﺼﻨﻊ اﻟﻤﺴﺠﻞ وﺑﺎﻟﺼﻨﺎدﻳﻖ ﻋﻼﻣﺎت ﺧﺎﺻﺔ‬
on the boxes to indicate the proper transportation ‫ﺗﻮﺿﺢ ﻃﺮﻳﻘﺔ اﻟﻨﻘﻞ واﻟﺘﺨﺰﻳﻦ اﻟﺼﺤﻴﺢ وﺳﻴﺘﻢ اﻟﻔﺤﺺ اﻟﻈﺎﻫﺮي‬
and storage method. External examination for the ‫ﻟﻠﺼﻨﺎدﻳﻖ واﻷﺟﻬﺰة ﻣﻦ ﻗﺒﻞ ﻓﺮﻳﻖ ﻣﻦ اﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت‬
boxes and devices shall be carried out by a technical ‫اﻟﻤﺸﺎرﻛﺔ وﻓﻲ ﺣﺎل وﺟﻮد أﻳﺔ ﻣﻼﺣﻈﺎت ﺳﻴﺘﻢ رﻓﺾ اﻟﺼﻨﺪوق‬
team from the Member States and Participating ‫ﺑﺎﻟﻜﺎﻣﻞ‬
Parties and in case an observations were found, the ‫ ﻓﻲ ﺣﺎل ﺗﻌﻄﻞ اﻟﺠﻬﺎز ﺧﻼل ﻓﺘﺮة اﻟﻀﻤﺎن واﻻﺣﺘﻴﺎج ﻟﻨﻘﻠﻪ ﺧﺎرج‬
boxes in entirety will be rejected. ‫اﻟﻤﺴﺘﺸﻔﻰ ﻟﻺﺻﻼح ﺗﺘﻜﻔﻞ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺘﺄﻣﻴﻦ ﺟﻬﺎز ﺑﺪﻳﻞ‬
• If the device experienced failure during the warranty ‫ﺧﻼل ﻓﺘﺮة اﻹﺻﻼح ﺣﺮﺻ ًﺎ ﻋﻠﻰ اﺳﺘﻤﺮارﻳﺔ اﻟﺨﺪﻣﺔ اﻟﻤﻘﺪﻣﺔ‬
period and there was a need to move it outside the
hospital, the manufacturer shall provide an
alternative device for the whole period of repair in
order to maintain the continuity of the provided
service.
• A printer that is compatible with the devices system and ‫ اﻻﻟﺘﺰام ﺑﺘﻮرﻳﺪ ﻃﺎﺑﻌﺔ ﺗﺘﻮاﻓﻖ ﻣﻊ ﻧﻈﺎم اﻟﺠﻬﺎز وﺗﺘﻮاﻓﻖ ﻣﻊ أﻧﻈﻤﺔ‬
with the systems of the Member States and ‫اﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ ﻟﻬﺎ ﻓﻲ ﺣﺎﻟﺔ ﻋﺪم وﺟﻮد ﻧﻈﺎم‬
participating parties shall be supplied in case of lack of ‫ﻣﺮﻛﺰ اﻟﺠﻬﺔ‬/‫اﻷرﺷﻔﺔ اﻹﻟﻜﺘﺮوﻧﻴﺔ )اﻟﺒﺎﻛﺲ( ﻓﻲ ﻣﺴﺘﺸﻔﻰ‬
the PACs system in the relevant hospital. ‫اﻟﻤﺸﺎرﻛﺔ‬
• UPS (including voltage stabilizer) shall be supplied with UPS Including Voltage ‫ اﻻﻟﺘﺰام ﺑﺘﻮﻓﻴﺮ وﺣﺪة ﻣﻨﻈﻢ اﻟﻄﺎﻗﺔ‬
each device supplied by the manufacturer and such ‫( ﻣﻊ ﻛﻞ ﺟﻬﺎز ﻳﺘﻢ ﺗﻮرﻳﺪه وﺗﻜﻮن اﻟﻮﺣﺪة إﻣﺎ داﺧﻠﻴﺔ‬Stabilizer)
UPS shall either be integrated (built in) or as external ‫)ﻣﺼﻤﻤﺔ داﺧﻞ اﻟﺠﻬﺎز( أو ﺧﺎرﺟﻴﺔ )ﻳﺘﻢ ﺗﻮرﻳﺪﻫﺎ ﻣﻊ اﻟﺠﻬﺎز( ﻣﻊ ﺗﻮﺿﻴﺢ‬
ّ
accessory and all details related to the specifications ‫ﻛﺎﻓﺔ اﻟﺘﻔﺎﺻﻴﻞ واﻟﻤﻮاﺻﻔﺎت وﺟﻬﺔ اﻟﺼﻨﻊ ﻟﻬﺎ ﺑﺎﻹﺿﺎﻓﺔ إﻟﻰ‬
and manufacturer's instructions shall be indicated. ‫ﺿﺮورة اﻻﻟﺘﺰام ﺑﻜﺎﻓﺔ اﻟﻤﻮاﺻﻔﺎت واﻟﺸﺮوط اﻟﺨﺎﺻﺔ ﺑﻤﺘﻄﻠﺒﺎت‬
Moreover, all specifications and conditions related to ‫اﻟﻄﺎﻗﺔ اﻟﻜﻬﺮﺑﺎﺋﻴﺔ اﻟﻮاردة ﻓﻲ ﺑﻨﻮد اﻟﻤﻮاﺻﻔﺎت واﻟﻤﺘﻄﻠﺒﺎت‬
power supply requirements as provided for in these ‫اﻟﺨﺎﺻﺔ ﺑﺎﻟﻄﺎﻗﺔ اﻟﻜﻬﺮﺑﺎﺋﻴﺔ اﻟﺴﺎﺑﻘﺔ وﺑﺸﺮط أن ﺗﻜﻮن ﻣﺼﻨّ ﻔﺔ‬
Conditions shall be abided by, provided that the ‫ﻟﻼﺳﺘﺨﺪام اﻟﻄﺒﻲ داﺧﻞ اﻟﻤﺴﺘﺸﻔﻴﺎت ﻣﻊ اﻋﺘﺒﺎر ﻫﺬه اﻟﻮﺣﺪة ﻣﻦ‬
equipment are classified for medical use inside ‫ﻣﻠﺤﻘﺎت اﻟﺠﻬﺎز اﻷﺳﺎﺳﻴﺔ وﻳﺴﺮي ﻋﻠﻴﻬﺎ ﻣﺎ ﻳﺴﺮي ﻋﻠﻰ اﻟﺠﻬﺎز ﻣﻦ‬
hospitals. And such UPS units shall be considered basic ‫ﺷﺮوط‬
equipment of the device and shall be subject to the
same conditions.
Installation and Startup :‫اﻟﺘﺮﻛﻴﺐ واﻟﺒﺪء ﻓﻲ اﻟﺘﺸﻐﻴﻞ‬
1. Manufacturer shall be responsible for the ‫ﺗﻌﺘﺒﺮ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻣﺴﺆوﻟﺔ ﻋﻦ اﻟﺘﺮﻛﻴﺐ واﻟﺘﺪرﻳﺐ واﻟﺒﺪء‬ -1
installation, training and startup of the equipment as
‫ﻌﺪات ﻛﻤﺎ ﺗﻨﺺ ﻋﻠﻴﻪ ﻣﻮاﺻﻔﺎت اﻟﺼﻨﻊ وﻫﺬا‬
ّ ‫ﻟﻠﻤ‬
ُ ‫ﻓﻲ اﻟﺘﺸﻐﻴﻞ‬
prescribed by the factory instructions, including but
‫ﻳﺘﻀﻤﻦ وﻻ ﻳﻘﺘﺼﺮ ﻋﻠﻰ ﻧﻘﻞ اﻷﺟﻬﺰة ﺑﺎﻟﻄﺮﻳﻘﺔ اﻟﺼﺤﻴﺤﺔ إﻟﻰ‬
not limited to the transportation of devices in an

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 12 of 21
appropriate manner, unloading, and moving the ‫اﻟﻤﻮﻗﻊ وإﻓﺮاغ اﻷﺟﻬﺰة اﻟﻤﻨﻘﻮﻟﺔ وﻧﻘﻠﻬﺎ إﻟﻰ اﻟﻤﻜﺎن اﻷﺧﻴﺮ‬
devices to the final site for installation where the
‫اﻟﻤﺨﺼﺺ ﻟﻬﺎ ﻟﻠﻘﻴﺎم ﺑﺘﺮﻛﻴﺐ اﻟﺠﻬﺎز وإﺟﺮاء اﻟﻤﻌﺎﻳﺮة وﺗﺠﺮﺑﺔ اﻷداء‬
calibration and performance testing will be carried
‫وﻓﺤﻮص اﻟﺴﻼﻣﺔ ﻋﻠﻰ اﻟﺠﻬﺎز وﺗﻘﺪﻳﻢ ﺷﻬﺎدات اﻟﻀﻤﺎن واﻹﺟﺎزة‬
out for the relevant device. Warranty certificate and
license shall be submitted upon request. A detailed ‫ﻋﻨﺪ اﻟﺤﺎﺟﺔ وﺗﻘﺪﻳﻢ ﺗﻘﺮﻳﺮ ﺧﺪﻣﺔ ﺗﻔﺼﻴﻠﻲ ﻟﻤﺎ ﻳﺘﻢ ﻋﻤﻠﻪ ﻟﻴﻘﻮم‬
service report shall be submitted showing all ‫اﻟﻤﻤﺜﻞ اﻟﻔﻨﻲ ﻟﻠﺒﺮﻧﺎﻣﺞ ﺑﻤﺮاﺟﻌﺘﻪ واﻟﻤﻮاﻓﻘﺔ ﻋﻠﻴﻪ ﻛﻤﺎ أن اﻟﺸﺮﻛﺔ‬
implemented services in order to be reviewed and ً
‫أﻳﻀﺎ ﻋﻦ ﺗﻮﻓﻴﺮ ﺟﻤﻴﻊ أﺟﻬﺰة اﻻﺧﺘﺒﺎر اﻟﻼزﻣﺔ وأي‬ ‫اﻟﺼﺎﻧﻌﺔ ﻣﺴﺆوﻟﺔ‬
approved by the program technician. Moreover, the ‫ﺑﻨﻮد أﺧﺮى ﺿﺮورﻳﺔ ﻟﻬﺬه اﻻﺧﺘﺒﺎرات ﻹﻧﻬﺎء إﺟﺮاءات اﻟﺘﺮﻛﻴﺐ وﺑﺪء‬
manufacturer shall be responsible for providing all
‫اﻟﺘﺸﻐﻴﻞ‬
required testing devices and any other items
necessary to carry out such test so as to complete
the installation and startup procedures.

2. The technician representing the relevant ‫ﺳﻴﺸﺮف اﻟﻤﻤﺜﻞ اﻟﻔﻨﻲ ﻟﻠﺠﻬﺔ اﻟﻤﺸﺎرﻛﺔ ﻋﻠﻰ اﻟﺘﺮﻛﻴﺐ‬ -2
participating party shall supervise the installation, ‫واﻟﺘﺸﻐﻴﻞ واﻟﺘﺪرﻳﺐ وﺟﻤﻴﻊ اﻹﺟﺮاءات اﻟﻼزﻣﺔ وﻳﻘﻮم ﺑﺎﻟﻤﻮاﻓﻘﺔ‬
operation and training and all other necessary ‫ﺑﻌﺪ اﻟﺘﺄﻛﺪ ﻣﻦ ﺟﻤﻴﻊ اﻹﺟﺮاءات اﻟﺴﺎﺑﻘﺔ‬
procedures and he/she shall be entitled to ensure
the enforcement of all aforementioned procedures.

3. If there is any field tasks, actions plans must be ‫ ﻳﺠﺐ اﻟﻤﻮاﻓﻘﺔ ﻋﻠﻰ ﺧﻄﻂ اﻟﻌﻤﻞ ﻗﺒﻞ اﺑﺘﺪاء اﻟﻌﻤﻞ ﻣﻦ ﻗﺒﻞ‬-3
approved by the relevant Engineering Departments ‫اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ ﺑﺎﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ إذا ﻛﺎن‬
in the Member States and Participating Parties ‫ﻫﻨﺎك ﻣﻬﺎم ﻣﻴﺪاﻧﻴﺔ‬
before initiation of the work.

4. Finished works shall be approved first by the ‫ اﻷﻋﻤﺎل اﻟﻤﻨﺘﻬﻴﺔ ﻳﺠﺐ اﻟﻤﻮاﻓﻘﺔ ﻋﻠﻴﻬﺎ ﻣﻦ ﻗﺒﻞ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ‬-4
Engineering Department in the Member States and ‫ﺑﺎﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ‬
Participating Parties.

5. It must be ensure that the craftwork and used ‫ ﻳﺠﺐ اﻟﺘﺄﻛﺪ ﻣﻦ أن ﺣﺮﻓﻴﺔ اﻟﺘﺮﻛﻴﺐ واﻟﻤﻮاد اﻟﻤﺴﺘﺨﺪﻣﺔ ﻣﻄﺎﺑﻘﺔ‬-5
materials conform to the international and local ‫ﻟﻠﻤﻮاﺻﻔﺎت اﻟﺪوﻟﻴﺔ واﻟﻤﺤﻠﻴﺔ وﻣﻮاﺻﻔﺎت اﻟﻤﺴﺘﺸﻔﻰ ﻛﻤﺎ ﻳﺠﺐ‬
specifications adopted by the relevant hospital. The ‫أن ﺗ ّﻮﻓﺮ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ أﻓﺮاد ﻣﺆﻫﻠﻴﻦ ﻟﻠﺘﺄﻛﺪ ﻣﻦ اﻟﺘﺮﻛﻴﺐ‬
manufacturer must provide qualified personnel to ‫واﻟﺘﺪرﻳﺐ وﺑﺪء اﻟﺘﺸﻐﻴﻞ اﻟﺴﻠﻴﻢ وﻣﻦ اﻟﻘﻴﺎم ﺑﺎﻟﻌﻤﻞ ﻓﻲ اﻟﻮﻗﺖ‬
ensure the proper installation, training and startup (‫ﺤﺪد )ﺗﺤﺖ إﺷﺮاف ﻣﺴﺆول اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ ﺑﺎﻟﻤﻮﻗﻊ‬
ّ ‫اﻟﻤ‬
ُ
and the implementation of the work on time (under
supervision by the in the site).

6. Supply of the parts of any devices shall not start ً


‫ﺟﺎﻫﺰا وﻓﻲ‬ ‫ ﻻ ﻳﺒﺪأ ﺗﻮرﻳﺪ أي ﻣﻦ أﺟﺰاء اﻟﺠﻬﺎز ﺣﺘﻰ ﻳﻜﻮن اﻟﻤﻮﻗﻊ‬-6
except until the site is ready and must be on time ‫اﻟﻮﻗﺖ اﻟﻤﻨﺎﺳﺐ ﻟﻺدارة اﻟﻬﻨﺪﺳﻴﺔ ﺑﺎﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت‬
that is appropriate for the Engineering Department ‫اﻟﻤﺸﺎرﻛﺔ وﻳﺘﻢ اﻟﺘﻮرﻳﺪ ﺑﻌﺪ ﺗﻘﺪﻳﻢ ﻃﻠﺐ ﻛﺘﺎﺑﻲ ﻟﻠﺠﻬﺔ اﻟﻤﺸﺎرﻛﺔ‬
in the Member States and Participating Parties. ‫ﻣﺤﺪد ﻓﻴﻪ اﻟﺒﻨﻮد اﻟﺘﻲ ﺗﻢ اﻻﺗﻔﺎق ﻋﻠﻰ ﺗﻮرﻳﺪﻫﺎ وﺗﺎرﻳﺦ اﻟﺘﻮرﻳﺪ‬
Supply process shall start after a written request to ‫وﻣﻮﻗﻊ اﻟﺘﻮرﻳﺪ‬
the participating party in which the parties will agree

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 13 of 21
on the items to be supplied, date of supply and
location of delivery.

Supply Conditions ‫ﺷﺮوط اﻟﺘﻮرﯾـﺪ‬


Kingdom of Saudi Arabia ‫اﻟﻤﻤﻠﻜﺔ اﻟﻌﺮﺑﻴﺔ اﻟﺴﻌﻮدﻳﺔ‬
United Arab Emirates ‫دوﻟﺔ اﻹﻣﺎرات اﻟﻌﺮﺑﻴﺔ اﻟﻤﺘﺤﺪة‬
Kingdom of Bahrain ‫ﻣﻤﻠﻜـــﺔ اﻟﺒﺤﺮﻳﻦ‬
Oman ‫ﺳﻠﻄﻨﺔ ﻋﻤﺎن‬
Qatar ‫دوﻟﺔ ﻗﻄﺮ‬
Kuwait ‫دوﻟــﺔ اﻟﻜﻮﻳـــﺖ‬
1- Manufacturer shall fully and comprehensively ‫ﺷﺎﻣﻼ‬
ً ‫ﻛﺎﻣﻼ‬
ً ً
‫ﺿﻤﺎﻧﺎ‬ ‫ ﺗﻀﻤﻦ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻣﺎ ﺗﻘﻮم ﺑﺘﻮرﻳﺪه‬-1
guarantee the supplied items as well as all works and ‫ﺟﻤﻴﻊ اﻷﻋﻤﺎل واﻟﻤﻮاد واﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ وذﻟﻚ ﻟﻤﺪة ﺧﻤﺲ‬
medical equipment for a period of five year as of the ً
‫اﻋﺘﺒﺎرا ﻣﻦ ﺗﺎرﻳﺦ اﻟﺘﺸﻐﻴﻞ اﻟﻔﻌﻠﻲ )ﺗﺎرﻳﺦ ﻣﺤﻀﺮ اﻟﺘﺮﻛﻴﺐ‬ ‫ﺳﻨﻮات‬
date of actual startup (the date of installation, (‫واﻟﺘﺸﻐﻴﻞ واﻟﺘﺪرﻳﺐ‬
operation and training minutes). ‫اﻟﻤﺠﺪوﻟﺔ‬
ُ ‫وﻳﺸﻤﻞ ﻫﺬا اﻟﻀﻤﺎن أﻋﻤﺎل اﻟﺼﻴﺎﻧﺔ اﻟﺮوﺗﻴﻨﻴﺔ واﻟﺪورﻳﺔ‬
This warranty period shall include the routine, regular ‫اﻟﻼزﻣﺔ وأﻋﻤﺎل اﻟﻤﻌﺎﻳﺮة وأﻋﻤﺎل اﻟﺰﻳﺎرات اﻟﻄﺎرﺋﺔ ﺣﺴﺐ ﺗﻌﻠﻴﻤﺎت‬
and scheduled maintenance works, calibration works, ‫اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻛﻤﺎ ﻳﺸﻤﻞ ﺗﻮﻓﻴﺮ اﻟﻌﻤﺎﻟﺔ واﻷدوات وﻗﻄﻊ‬
and emergency visits according to the manufacturer's ‫اﻟﻐﻴﺎر اﻟﻼزﻣﺔ ﻟﻺﺻﻼح واﻟﺼﻴﺎﻧﺔ واﻟﻤﺤﺎﻓﻈﺔ ﻋﻠﻰ اﻷﺟﻬﺰة ﻓﻲ‬
instructions. This also shall include the provision of the ‫ﺣﺎﻟﺔ ﺗﺸﻐﻴﻠﻴﺔ ﺑﺎﻟﻜﻔﺎءة اﻟﺘﺎﻣﺔ وذﻟﻚ اﻣﺘﺪاد ﻓﺘﺮة اﻟﻀﻤﺎن‬
spare parts and tools necessary for repairing and
maintaining the devices in a full operational status for
the entire warranty period.

2- Medical devices which proved ineffective due to poor ً


‫ﻋﻤﻠﻴﺎ ﻋﺪم ﺟﺪواﻫﺎ ﻧﺘﻴﺠﺔ ﻟﻠﺨﻠﻞ‬ ‫ ﺗُ ﺴﺘﺒﺪل اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ اﻟﺘﻲ ﻳﺜﺒﺖ‬-2
manufacturing or installation shall be replaced. And ‫اﻟﺤﺎدث ﻓﻲ اﻟﺘﺼﻨﻴﻊ أو اﻟﺘﺮﻛﻴﺐ أو ﻓﻲ ﺣﺎل ﺣﺼﻮل اﺳﺘﺪﻋﺎء‬
in case the relevant device was recalled by the FDA, ‫ ﺧﻼل ﺷﻬﺮﻳﻦ ﻣﻦ ﺗﺎرﻳﺦ‬FDA ‫ﻟﻠﺠﻬﺎز ﻣﻦ ﻗﺒﻞ ﻫﻴﺌﺔ اﻟﻐﺬاء واﻟﺪواء‬
the device shall be replaced by the manufacturer ‫ ﻣﻦ ﻗﺒﻞ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ واﻟﺘﻮرﻳﺪ ﻋﻠﻰ ﺣﺴﺎﺑﻪ ﺑﻨﻔﺲ‬،‫اﻟﺒﻼغ‬
within two months of recall notice; in which case the ‫اﻟﺸﺮوط واﻟﻤﻮاﺻﻔﺎت اﻟﻤﻄﺮوﺣﺔ ﻓﻲ اﻟﻤﻨﺎﻓﺴﺔ‬
supply shall be carried out by the manufacturer at its
own expense on the same conditions of the relevant
tender.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 14 of 21
3. Awarded bidder shall provide a certificate of origin ‫ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺗﻘﺪﻳﻢ ﺷﻬﺎدة ﻣﻨﺸﺄ ﻋﻨﺪ ﺗﻮرﻳﺪ اﻟﺒﻨﻮد‬-3
upon supplying the awarded items and shall ensure ‫اﻟﻤ ّﻮرد ﻣﻦ ﻧﻔﺲ اﻟﺸﺮﻛﺔ‬
ُ ‫اﻟﻤﺮﺳﻰ ﻋﻠﻴﻬﺎ ﻳﺘﻢ اﻻﻟﺘﺰام ﺑﺄن اﻟﺠﻬﺎز‬
that the supplied device is manufactured by the ‫ﺼﺪﻗﺔ‬
ّ ‫اﻟﻤﻨﺼﻮص ﻋﻠﻴﻬﺎ ﻓﻲ اﻟﻌﺮض وﻣﻦ ﺗﺼﻨﻴﻌﻬﺎ وأن ﺗﻜﻮن ُﻣ‬
company stated in the bid. And the certificate of origin ‫ﻣﻦ اﻟﺠﻬﺔ اﻟﺤﻜﻮﻣﻴﺔ اﻟﻤﺴﺆوﻟﺔ ﻓﻲ ﺑﻠﺪ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ وﻣﻦ‬
must be attested by the concerned government ‫إﺣﺪى ﺳﻔﺎرات دول ﻣﺠﻠﺲ اﻟﺘﻌﺎون اﻟﺨﻠﻴﺠﻲ أو ﻣﻦ ﻳﻘﻮم ﻣﻘﺎﻣﻬﺎ‬
department in the country of the manufacturer and by ‫ﺿﻤﻦ أي ﺳﻔﺎرة ﻋﺮﺑﻴﺔ أو ﻣﻦ اﻟﻐﺮف اﻟﺘﺠﺎرﻳﺔ أو ﻣﻦ اﺗﺤﺎد‬
one of the embassies of the GCC counties, by the ‫اﻟﺼﻨﺎﻋﺎت ﻛﻤﺎ ﻳﻤﻜﻦ ﻗﺒﻮل ﺷﻬﺎدة اﻟﻤﻨﺸﺄ ﻣﻦ ﺑﻠﺪ اﻟﺘﺼﺪﻳﺮ ﻋﻠﻰ‬
relevant Chambers of Commerce or by the Federation ‫أن ﻳﺒﻴﻦ ﺑﻬﺎ اﺳﻢ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ وﺑﻠﺪ اﻹﻧﺘﺎج ورﻗﻢ اﻟﺘﺴﻠﺴﻞ‬
of Industries. The certificate of origin from the ‫ﻟﻠﺠﻬﺎز اﻟﻄﺒﻲ‬
exporting country may be accepted provided that the
manufacturer's name, country of production and the
serial number of medical device must be indicated
therein.

4. The warranty period shall start from the date of ‫ ﻳﺠﺐ أن ﺗﺒﺪأ ﻓﺘﺮة اﻟﻀـــﻤﺎن ﻣﻦ ﺗﺎرﻳﺦ ﻣﺤﻀـــﺮ اﻟﺘﺮﻛﻴﺐ واﻟﺘﺸـــﻐﻴﻞ‬-4
installation, operation and training minutes as signed ‫وﻳ ﻌﺪ ﺗﻮﻗﻴﻊ ﻫﺬا‬
ُ ‫اﻟﺠﻬﺔ اﻟﻤﺸـــــــﺎرﻛﺔ‬/‫واﻟﺘﺪرﻳﺐ ُﻣ ّﻮﻗﻊ ﻣﻦ اﻟﻮزارة‬
by the Ministry/participating party. The signature ‫اﻟﻤﺤﻀــــﺮ ﻫﻮ اﻟﻘﺒﻮل اﻟﻨﻬﺎﺋﻲ ﻟﻠﺠﻬﺎز وﻳﺠﺐ أن ﻳﺸــــﻤﻞ اﻟﻀــــﻤﺎن‬
upon the said minutes shall constitute final ‫اﻟﻤﺠﺪوﻟﺔ ﺣ ﺴﺐ ﺗﻮ ﺻﻴﺎت اﻟﻤ ﺼﻨﻊ‬
ُ ‫ﻗﻄﻊ اﻟﻐﻴﺎر واﻟ ﺼﻴﺎﻧﺔ اﻟﺪورﻳﺔ‬
acceptance of the relevant device. Warranty must ‫وﻳ ﺸﻤﻞ أﻳ ﻀﺎ اﻟﻌﻤﺎﻟﺔ وﺗﻜﺎﻟﻴﻒ ﺳﻔﺮﻫﻢ وﺗﻜﺎﻟﻴﻒ اﻟ ﺸﺤﻦ ﻟﺠﻤﻴﻊ‬
include spare parts and periodical scheduled ‫اﻷﺟﺰاء اﻟﺨﺎﺻﺔ ﺑﺠﻤﻴﻊ اﻷﺟﻬﺰة اﻟﻤﺘﻀﻤﻨﺔ ﺑﺨﻄﺎب اﻟﺘﺮﺳﻴﺔ‬
maintenance according to the manufacturer's
instructions, and shall also include specialized
personnel costs (travel and shipment costs for all parts
related to the devices contained in the letter of
award).

5. Manufacturer shall ensure that the medical device is ‫ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ أن ﺗﻀﻤﻦ ُﺧﻠﻮ اﻟﺠﻬﺎز ﻣﻦ اﻟﻌﻴﻮب واﻟﺨﻠﻞ‬-5
free of any defect in the materials, craftsmanship, ‫ﻓﻲ اﻟﻤﻮاد اﻟﺨﺎم وﺣﺮﻓﻴﺔ أﻋﻤﺎل اﻟﺘﺼﻨﻴﻊ واﻟﺘﺮﻛﻴﺐ وﺗﻜﺎﻣﻞ اﻷﺟﺰاء‬
installation and integrity of the parts.

6. Upon the expiry of warranty period, a final receipt ‫ ﻋﻨﺪ اﻧﺘﻬﺎء ﻓﺘﺮة اﻟﻀﻤﺎن ﻳﺠﺐ إﻋﺪاد ﻣﺤﻀﺮ اﺳﺘﻼم ﻧﻬﺎﺋﻲ ﻟﻠﺠﻬﺎز‬-6
minutes for the relevant device shall be prepared and ‫ﻓﻨﻴﺔ ﺗﻀﻢ ﺛﻼﺛﺔ ﻣﻬﻨﺪﺳﻴﻦ ﻣﻤﺜﻠﻴﻦ‬
ّ ‫ﻣﻦ ﺧﻼل ﻣﻮاﻓﻘﺔ أﻋﻀﺎء ﻟﺠﻨﺔ‬
contain approval by a technical committee of three ‫ﻋﻦ ﻛﻞ ﻣﻦ )اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ – إدارة اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ ﻟﻠﺠﻬﺔ‬
engineers who are representatives of (the ‫اﻟﻤﺸﺎرﻛﺔ – إدارة اﻟﺼﻴﺎﻧﺔ ﻟﻠﺠﻬﺔ اﻟﻤﺸﺎرﻛﺔ( وﻻ ﻳﺘﻢ ﺗﻮﻗﻴﻊ أﻋﻀﺎء‬
manufacturer, Department of Medical Devices of the ‫اﻟﻠﺠﻨﺔ إﻻ ﺑﻌﺪ اﻟﺘﺄﻛﺪ ﻣﻦ إﻧﻬﺎء ﻛﺎﻓﺔ اﻟﻤﻼﺣﻈﺎت اﻟﻔﻨﻴﺔ اﻟﺨﺎﺻﺔ‬
participating party, and Department of Maintenance ‫اﻟﻔﻨﻴﺔ واﻟﺘﺸﻐﻴﻠﻴﺔ‬
ّ ‫ﺑﺎﻟﺠﻬﺎز وأﻧﻪ ﺧﺎﻟﻲ ﻣﻦ اﻷﻋﻄﺎل واﻟﻤﻼﺣﻈﺎت‬
of the Participating Party); the members of the said ‫ﺣﻴﺚ ﻳﺘﻢ اﻟﺘﻮﻗﻴﻊ وﺧﺘﻢ اﻟﻤﺤﻀﺮ ﺛﻢ اﻋﺘﻤﺎده ﻣﻦ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ‬
committee may not sign except after ensuring that all ‫ﺑﺎﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ‬
technical observations on the device are settled and
that the device is free of faults and operational
defects, and then the minutes can be signed, sealed

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 15 of 21
and approved by the Engineering Department in the
Member States and Participating Parties.

7. Manufacturer shall submit a schedule of preventive ‫ ﻳﺠﺐ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺗﻘﺪﻳﻢ ﺟﺪول ﻣﻮاﻋﻴﺪ زﻳﺎرات اﻟﺼﻴﺎﻧﺔ‬-7
and periodical maintenance visits, and shall abide by ‫اﻟﻮﻗﺎﺋﻴﺔ اﻟﺪورﻳﺔ واﻟﺬي ﻳﻌﺘﺒﺮ إﻟﺰاﻣﻲ ﻟﻠﺘﻘﻴﺪ ﺑﻪ ﺧﻼل ﻓﺘﺮة اﻟﻀﻤﺎن‬
such schedule for the entire period of warranty in ‫ﺣﺴﺐ ﺗﻮﺻﻴﺎت اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ‬
accordance with the manufacturer's instructions.

8. Manufacturer shall carry out the periodical and ‫ ﺗﻠﺘﺰم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺎﻟﻘﻴﺎم ﺑﺰﻳﺎرات اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ اﻟﺪورﻳﺔ‬-8
preventive maintenance visits on time, and a technical ‫ﻓﻲ ﻣﻮاﻋﻴﺪﻫﺎ وﻳﺘﻢ ﺗﻘﺪﻳﻢ ﺗﻘﺮﻳﺮ ﻓﻨﻲ ﻣﻊ ﻛﻞ زﻳﺎرة ﻳﻮﺿﺢ ﻓﻴﻬﺎ‬
report shall be submitted after each visit in which the ‫( وأﻋﻤﺎل اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ واﻟﻤﻌﺎﻳﺮة‬Check List) ‫ﻗﺎﺋﻤﺔ اﻟﻔﺤﺺ‬
Checklist shall be indicated as well as the ً
‫ﻃﺒﻘﺎ ﻟﺘﻮﺻﻴﺎت‬ ‫واﺧﺘﺒﺎرات اﻷﻣﺎن اﻟﺘﻲ ﺗﺘﻢ ﺧﻼل اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ‬
maintenance, calibration and safety tests carried out ‫اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ‬
during the preventive maintenance visits according to
the manufacturer's instructions.

9. Scheduled preventive maintenance and corrective ‫اﻟﻤﺠﺪوﻟﺔ واﻟﺼﻴﺎﻧﺔ اﻟﺘﺼﺤﻴﺤﻴﺔ ﻣﻦ‬


ُ ‫ ﻳﺠﺐ ﺗﻨﻔﻴﺬ اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ‬-9
maintenance works shall be carried out by ‫ﻗﺒﻞ ﻣﻬﻨﺪﺳﻲ ﺻﻴﺎﻧﺔ ﻣﺆﻫﻠﻴﻦ ﻟﺪى اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ وأن ﺗﺘﻢ ﻫﺬه‬
maintenance engineers qualified by the ً
‫ﻃﺒﻘﺎ ﻟﻤﻮاﺻﻔﺎت اﻟﺘﺼﻨﻴﻊ وﻣﻄﺎﺑﻘﺔ ﻷﺻﻮل اﻟﻤﻤﺎرﺳﺔ‬ ‫اﻟﺼﻴﺎﻧﺔ‬
manufacturer; such maintenance works must be ‫اﻟﻤﺠﺪوﻟﺔ ﻣﻌﺎﻳﺮة دورﻳﺔ ﻟﻠﺠﻬﺎز‬
ُ ‫اﻟﻬﻨﺪﺳﻴﺔ وﻳﺠﺐ أن ﺗﺸﻤﻞ اﻟﺼﻴﺎﻧﺔ‬
implemented in accordance with the factory ‫ﻟﻀﻤﺎن دﻗﺘﻪ وﻛﻔﺎءﺗﻪ ﺑﺎﺳﺘﺨﺪام "أﺣﺪث أﺟﻬﺰة اﻟﻤﻌﺎﻳﺮة اﻟﻤﻌﺘﻤﺪة‬
instructions and in compliance with the best ً
‫ﺳﻨﻮﻳﺎ ﻣﻦ اﻟﺠﻬﺔ اﻟﻤﺨﺘﺼﺔ ﺑﺎﻟﺪول اﻷﻋﻀﺎء‬
engineering practices. The periodical maintenance
shall include regular calibration for the device to
ensure its efficiency and accuracy by the use of the
latest calibration tools approved by competent
authority in the Member States.

10. Maintenance engineer shall perform the scheduled ‫ ﻳﻘﻮم ﻣﻬﻨﺪس اﻟﺼﻴﺎﻧﺔ ﺑﺈﺟﺮاء اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ اﻟﻤﺠﺪوﻟﺔ ﻟﻠﺠﻬﺎز‬-10
preventative maintenance for the device and all its ً
‫ﻃﺒﻘﺎ ﻟﻠﻔﺘﺮات اﻟﻤﺤﺪدة ﻣﻦ ﻗﺒﻞ اﻟﻤﺼﻨﻊ وﻋﻠﻰ‬ ‫وﻟﻜﺎﻓﺔ ﻣﻜﻮﻧﺎﺗﻪ‬
parts in accordance with the time limits specified by ‫ﺟﺪوﻻ ﺑﺎﻟﺼﻴﺎﻧﺔ‬
ً ً
‫أﻳﻀﺎ أن ﺗﻘﺪم ﻟﻠﻤﻤﺜﻞ اﻟﻔﻨﻲ‬ ‫اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ‬
the factory, and the manufacturer shall also provide ً
‫ﻃﺒﻘﺎ ﻟﺘﻮﺟﻴﻬﺎت اﻟﻤﺼﻨﻊ وﻳﺘﻢ اﻋﺘﻤﺎد ﻫﺬا‬ ‫اﻟﻤﺠﺪوﻟﺔ‬
ُ ‫اﻟﻮﻗﺎﺋﻴﺔ‬
the technical representative with the schedule of ‫اﻟﺠﺪول ﻣﻦ ﻗﺒﻞ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ ﺑﺎﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت‬
prescribed preventive maintenance according to the ‫اﻟﻤﺸﺎرﻛﺔ ﻳﻮﺿﺢ ﻓﻲ ذﻟﻚ اﻟﺠﺪول اﻟﺘﻮارﻳﺦ وﻓﺘﺮات اﻟﺰﻳﺎرات‬
factory's instructions and such schedule shall be ‫ ﻳﻮم ﻋﻠﻰ اﻷﻗﻞ ﻓﻲ‬14 ‫وﺗﻜﺮارﻫﺎ وﻳﺠﺐ إرﺳﺎل إﺷﻌﺎر ﻛﺘﺎﺑﻲ ﻗﺒﻞ‬
approved by the Engineering Departments in the ‫ﺗﻘﺮر إﺟﺮاء ﺗﻌﺪﻳﻞ ﻋﻠﻰ اﻟﺒﺮﻧﺎﻣﺞ اﻟﺬي ﺳﺒﻖ اﻋﺘﻤﺎده‬
ّ ‫ﺣﺎل‬
Member States and Participating Parties. The said
schedule shall indicate the dates, periods and
frequency of visits and a written notice shall be sent
14 days at least in advance in case any amendment
was introduced to the previously approved schedule.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 16 of 21
11. Manufacturer shall provide written instructions ‫ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺗﻘﺪﻳﻢ إﺟﺮاءات ﻛﺘﺎﺑﻴﺔ ﺗﺘﻌﻠﻖ ﺑﺎﻟﺼﻴﺎﻧﺔ‬-11
related to the preventive maintenance, performance, ‫اﻟﻮﻗﺎﺋﻴﺔ واﻷداء واﻟﺴﻼﻣﺔ واﻟﻤﻌﺎﻳﻨﺎت اﻟﺨﺎﺻﺔ ﺑﺎﻟﻤﻌﺎﻳﺮة ﻣﻊ‬
safety, and tests relative to the calibration. Such ‫ﺿﺮورة ﺗﻮﺿﻴﺤﻬﺎ وﺗﺴﻠﻴﻢ ﻧﺴﺨﺔ ﻣﻨﻬﺎ إﻟﻰ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ‬
instructions shall be clarified and handed over to the ‫ﺑﺎﻟﻤﻮﻗﻊ‬
Engineering Dept. in the site .

12. Throughout the Warranty Period, the manufacturer ‫ أﺛﻨﺎء ﻓﺘﺮة اﻟﻀﻤﺎن ﺗﻜﻮن اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻣﺴﺆوﻟﺔ ﻋﻦ اﻹﺻﻼح‬-12
shall be responsible for the repair, maintenance and ‫واﻟﺼﻴﺎﻧﺔ واﻟﺘﺸﻐﻴﻞ اﻟﺠﻴﺪ ﻟﻠﺠﻬﺎز وﻳﺠﺐ ﺻﻴﺎﻧﺔ اﻟﺠﻬﺎز ﻟﻜﻲ ﻳﻔﻲ‬
proper operation of the device. The Device must be ‫ﺑﻤﻘﺎﻳﻴﺲ اﻷداء واﻟﺴﻼﻣﺔ اﻟﻤﺤﺪدة ﻣﻦ ﻗﺒﻞ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ‬
maintained in order to meet the performance and ‫ﺑﺎﻟﺠﻬﺔ اﻟﻤﺸﺎرﻛﺔ وﻛﺬﻟﻚ ﻳﺠﺐ ﺻﻴﺎﻧﺔ اﻟﺠﻬﺎز ﺑﺤﻴﺚ ﻳﺆﻣﻦ اﻟﺴﻼﻣﺔ‬
safety standards determined by the Engineering Dept. ‫ﻣﻦ اﻟﻌﻮاﻣﻞ اﻟﺤﺮارﻳﺔ واﻟﻜﻴﻤﺎوﻳﺔ واﻟﻜﻬﺮﺑﺎﺋﻴﺔ واﻹﺷﻌﺎﻋﻴﺔ‬
in the Participating Party. The device shall be ‫واﻟﺰوار أو اﻟﺘﻠﻒ‬
ّ ‫واﻹﺻﺎﺑﺎت اﻟﻤﻴﻜﺎﻧﻴﻜﻴﺔ ﻟﻠﻤﻮﻇﻔﻴﻦ واﻟﻤﺮﺿﻰ‬
maintained and protected against the thermal, ً
‫ﻣﻄﺎﺑﻘﺎ ﻵﺧﺮ‬ ‫ﻓﻲ اﻟﻤﺮاﻓﻖ أو اﻟﻤﻌﺪات وﻳﺠﺐ أن ﻳﻜﻮن اﻟﺠﻬﺎز‬
chemical, electrical and radiological factors in order (OSHA, IEC, AAMI, ‫وأﺣﺪث اﻟﻤﺘﻄﻠﺒﺎت ﺑﻤﺎ ﻓﻲ ذﻟﻚ اﻟﺘﻌﺪﻳﻼت‬
not to cause mechanical injuries of staff, patients and ‫ وﻓﻲ ﺣﺎل ﺣﺪوث ﺗﺸﺎﺑﻪ ﻓﻲ اﻟﻤﺘﻄﻠﺒﺎت ﻓﺴﻮف‬ANSI, NFPA)
visitors, or damage to facilities or equipment. The ‫ﻳﺘﻢ ﻋﻨﺪﺋﺬ ﺗﻄﺒﻴﻖ أﻛﺜﺮ اﻟﻤﻘﺎﻳﻴﺲ أو اﻟﻨﻈﻢ دﻗﺔ‬
device must comply with the latest requirements
including (OSHA, IEC, AAMI, ANSI, NFPA) and in case
of similarity of requirements, then the most accurate
and strict systems or standards shall be applied.

13. Any faults discovered and left unrepaired after ‫ ﻳﺠﺐ اﻹﺑﻼغ ﻋﻦ أﻳﺔ أﻋﻄﺎل ﺗﻜﺘﺸﻒ وﺗﺘﺮك دون إﺻﻼح ﻋﻘﺐ‬-13
completion of scheduled preventive and corrective ‫اﻟﻤﺠﺪوﻟﺔ أو اﻟﺘﺼﺤﻴﺤﻴﺔ وﻓﻲ ﺣﺎل‬
ُ ‫اﻻﻧﺘﻬﺎء ﻣﻦ اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ‬
maintenance shall be reported. In case there is a need ‫ﻳﻨﻮﻩ ﻓﻲ ﺗﻘﺮﻳﺮ اﻟﺼﻴﺎﻧﺔ إﻟﻰ‬
ّ ‫اﻟﺤﺎﺟﺔ ﻟﺰﻳﺎرة ﻣﺘﺎﺑﻌﺔ اﻟﺼﻴﺎﻧﺔ ﻳﺠﺐ أن‬
for maintenance follow up visit, then the maintenance ‫ﺗﺎرﻳﺦ وﻗﺖ ﻫﺬه اﻟﺰﻳﺎرة وﻋﻠﻰ اﻟﻤﻬﻨﺪﺳﻴﻦ اﻟﻤﺪﻧﻴﻴﻦ واﻟﺼﻴﺎﻧﺔ‬
report shall indicate the date and time specified for ‫واﻟﻜﻬﺮﺑﺎء اﻟﺤﻀﻮر ﻟﻤﻮﻗﻊ اﻟﺠﻬﺔ اﻟﻤﺸﺎرﻛﺔ ﻓﻲ ذﻟﻚ اﻟﺘﺎرﻳﺦ‬
such visit and the civil, maintenance and electricity ‫ﺑﺎﻟﺘﻨﺴﻴﻖ ﻣﻊ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ ﺑﺎﻟﻤﻮﻗﻊ ﻹﻛﻤﺎل اﻷﻋﻤﺎل اﻟﻀﺮورﻳﺔ‬
engineers shall attend in the site of the participating
party on that date in coordination with the
Engineering Dept. in the site in order to complete the
necessary works.

14. After the preventive maintenance visit, the ‫ ﺑﻌﺪ اﻟﺰﻳﺎرة اﻟﺨﺎﺻﺔ ﺑﺎﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ ﻳﻘﻮم ﻣﻬﻨﺪس اﻟﺼﻴﺎﻧﺔ‬-14
maintenance engineer shall place a sticker on the ‫ﺑﻮﺿﻊ ُﻣﻠﺼﻖ ﻋﻠﻰ اﻟﺠﻬﺎز ﻳﻮﺿﺢ ﺗﺎرﻳﺦ اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ واﺳﻢ‬
device to show the date of preventive maintenance ‫اﻟﻤﻮزع وﻣﻬﻨﺪﺳﻲ اﻟﺼﻴﺎﻧﺔ وﺗﺎرﻳﺦ إﺟﺮاء اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ‬
ُ / ‫اﻟﻮﻛﻴﻞ‬
visit, name of the agent/distributor, maintenance
engineers, and the date of performing the preventive
maintenance visit.

15. Manufacturer shall not remove any device, ‫ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻋﺪم إزاﻟﺔ أي ﺟﻬﺎز أو وﺛﺎﺋﻖ أو ﺑﺮاﻣﺞ أو أي‬-15
documents, programs or any parts from the site ‫ﻗﻄﻊ ﻣﻦ اﻟﻤﻮﻗﻊ إﻻ ﺑﻤﻮﺟﺐ ﺗﺼﺮﻳﺢ ﺧﻄﻲ ﻣﻦ اﻟﻤﻤﺜﻞ اﻟﻔﻨﻲ‬

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 17 of 21
except under a written authorization from the ‫ﻟﻠﻤﺸﺮوع وﻫﺬا ﻻ ﻳﻨﻄﺒﻖ ﻋﻠﻰ اﻟﻘﻄﻊ اﻟﺘﻲ ﺗﻘﻮم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ‬
technical representative of the project. This clause ‫اﻟﻤﺠﺪوﻟﺔ‬
ُ ‫ﺑﺈﺣﻀﺎرﻫﺎ إﻟﻰ اﻟﻤﻮﻗﻊ ﺑﻬﺪف إﻛﻤﺎل اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ أو‬
shall not apply to the spare parts which the ‫وﻣﻌﺪات اﻻﺧﺘﺒﺎر واﻟﺘﺸﺨﻴﺺ واﻟﻜﺘﻴﺒﺎت‬
ُ ‫وﺗﺸﻤﻞ اﻟﻘﻄﻊ واﻷدوات‬
manufacturer brings to the site in order tom complete ‫وﺑﺮاﻣﺞ اﻟﺤﺎﺳﻮب اﻟﺘﻲ ﺗﻌﻮد ﻣﻠﻜﻴﺘﻬﺎ ﻟﻠﺒﺎﺋﻊ‬
the preventive or scheduled maintenance including
the parts, tools, testing equipment, diagnosis tools,
manuals and software owned by the seller.

16. The manufacturer shall be responsible for the proper ‫ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻣﺴﺆوﻟﺔ ﻋﻦ اﻟﺘﺨﻠﺺ ﺑﻄﺮﻳﻘﺔ ﻣﻨﺎﺳﺒﺔ وآﻣﻨﺔ‬-16
and safe elimination of spare parts, liquids and any ‫ﻣﻦ ﻗﻄﻊ اﻟﻐﻴﺎر واﻟﻤﻮاد واﻟﺴﻮاﺋﻞ وأﻳﺔ ﻗﻄﻊ أﺧﺮى اﺳﺘﻌﻤﻠﺖ ﻓﻲ‬
other materials used in the maintenance and service ‫أﻧﻮاع ﻣﻦ اﻟﺼﻴﺎﻧﺔ أو اﻟﺨﺪﻣﺔ‬
process.

17. All works of scheduled preventive or corrective ‫اﻟﻤﺠﺪوﻟﺔ أو اﻟﺼﻴﺎﻧﺔ اﻟﺘﺼﺤﻴﺤﻴﺔ‬


ُ ‫ ﺟﻤﻴﻊ أﻋﻤﺎل اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ‬-17
maintenance shall be carried out during normal ‫ﻳﺠﺐ أن ﺗﺘﻢ أﺛﻨﺎء ﺳﺎﻋﺎت اﻟﻌﻤﻞ اﻟﻤﻌﺘﺎدة ﻓﻲ اﻟﺠﻬﺔ اﻟﻤﺸﺎرﻛﺔ‬
working hours of the Participating Party and in ‫وﺑﺎﻟﺘﻨﺴﻴﻖ ﻣﻊ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ ﺑﺎﻟﻤﻮﻗﻊ إﻻ إذا ﺗﻢ اﻻﺗﻔﺎق ﻋﻠﻰ‬
accordance with the Engineering Dept. in the site, ‫ﺗﺮﺗﻴﺐ ﻣﻐﺎﻳﺮ ﻟﺬﻟﻚ‬
unless another arrangement is agreed upon.

18. The manufacturer shall provide the technical ‫ ﺗﻘﻮم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺘﺰوﻳﺪ ﻣﻤﺜﻞ اﻟﺒﺮﻧﺎﻣﺞ اﻟﻔﻨﻲ ﺑﺠﻤﻴﻊ أرﻗﺎم‬-18
representative of the program with all telephone and ‫اﻟﻬﻮاﺗﻒ واﻟﻔﺎﻛﺴﺎت واﻟﺒﺮﻳﺪ اﻹﻟﻜﺘﺮوﻧﻲ واﻷﺳﻤﺎء اﻟﺨﺎﺻﺔ‬
fax numbers, email address and names of ‫ﺑﻤﻬﻨﺪﺳﻲ اﻟﺼﻴﺎﻧﺔ واﻟﻤﺴﺆوﻟﻴﻦ ﻋﻦ ﺗﻘﺪﻳﻢ اﻟﺼﻴﺎﻧﺔ ﺑﺎﻷﺟﻬﺰة‬
maintenance engineers responsible for the provisions ‫وﺗﻘﻮم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺈﻳﻀﺎح ﻛﻴﻔﻴﺔ اﻟﺤﺼﻮل ﻋﻠﻰ ﺧﺪﻣﺎت‬
of maintenance services to the devices. The ‫اﻟﺼﻴﺎﻧﺔ أﺛﻨﺎء اﻟﺤﺎﻻت اﻟﻄﺎرﺋﺔ إذا دﻋﺖ اﻟﺤﺎﺟﺔ ﺑﻌﺪ ﺳﺎﻋﺎت اﻟﻌﻤﻞ‬
manufacturer shall clarify the method of procuring the
maintenance services in emergency cases if need
arises after the working hours.

19. Maintenance shall include any additional works ‫ ﺗﺸﻤﻞ اﻟﺼﻴﺎﻧﺔ إي أﻋﻤﺎل إﺿﺎﻓﻴﺔ ﻣﻄﻠﻮﺑﺔ ﻟﻠﺤﻔﺎظ ﻋﻠﻰ‬-19
required in order to maintain the equipment in a good ‫ﻌﺪات ﻓﻲ ﺣﺎﻟﺔ ﺗﺸﻐﻴﻠﻴﺔ ﺑﺎﻟﻜﻔﺎءة اﻟﻤﻄﻠﻮﺑﺔ‬
ّ ‫اﻟﻤ‬
ُ
and efficient operational situation.

20. The manufacturer shall provide an online ‫ ﻟﻠﻤﻮاﻗﻊ‬On line service ‫ ﺗﻠﺘﺰم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺘﻮﻓﻴﺮ ﺧﺪﻣﺔ‬-20
maintenance service for the sites where the internet ‫اﻟﺘﻲ ﺗﺘﻮﻓﺮ ﻓﻴﻬﺎ ﺧﺪﻣﺔ اﻹﻧﺘﺮﻧﺖ‬
access is available.

21. During the first three months following the receipt of ‫ﺗﻘﻮم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺧﻼل اﻷﺷﻬﺮ اﻟﺜﻼث اﻷوﻟﻰ ﺑﻌﺪ‬ -21
the award letter, the manufacturer shall provide the ‫اﺳﺘﻼم ﺧﻄﺎب اﻟﺘﺮﺳﻴﺔ ﺑﺘﻮﻓﻴﺮ اﻟﻤﺴﺎﻋﺪة اﻟﻔﻨﻴﺔ اﻟﻼزﻣﺔ ﻟﺘﺸﻐﻴﻞ‬
necessary technical assistance for the operation of the ‫اﻟﺠﻬﺎز وﺗﻄﺒﻴﻘﺎﺗﻪ ﻋﻨﺪ ﻃﻠﺐ اﻟﻤﺴﺘﺸﻔﻰ‬
device and its applications upon request by the
hospital.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 18 of 21
22. Manufacturer shall provide all required consumables ‫ ﺗﻠﺘﺰم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺘﻮﻓﻴﺮ ﺟﻤﻴﻊ اﻟﻤﻮاد اﻻﺳﺘﻬﻼﻛﻴﺔ اﻟﻼزﻣﺔ‬-22
during the training period. .‫ﺧﻼل ﻓﺘﺮة اﻟﺘﺪرﻳﺐ‬

Documents to be submitted before the supply and ‫اﻟﻤﺴﺘﻨﺪات اﻟﻮاﺟﺐ ﺗﻘﺪﻳﻤﻬﺎ ﻗﺒﻞ ﺗﻮرﻳﺪ وﺗﺮﻛﻴﺐ اﻷﺟﻬﺰة‬
installation of the medical devices in the specified site: :‫اﻟﻤﺤﺪد‬
ّ ‫اﻟﻄﺒﻴﺔ ﻓﻲ اﻟﻤﻮﻗﻊ‬
ّ
1. The final As-Built drawings showing the locations for ً
‫ﻣﺒﻴﻨﺎ ﻋﻠﻴﻬﺎ‬ AS-BUILD ‫اﻟﻤﺨﻄﻄﺎت اﻟﻤﻌﻤﺎرﻳﺔ اﻟﺘﻨﻔﻴﺬﻳﺔ اﻟﻨﺎﺋﻴﺔ‬
ُ -1
the devices and equipment and the plans for
‫ﻣﻮاﻗﻊ اﻷﺟﻬﺰة واﻟﻤﻌﺪات وﺟﺪاول ﺗﻮزﻳﻌﻬﺎ ﻋﻠﻰ اﻟﻐﺮف واﻟﺠﺪاول‬
distribution of the same to the rooms, assembly tables
‫اﻟﺘﺠﻤﻴﻌﻴﺔ وﻣﺨﻄﻄﺎت أﻋﻤﺎل ﻣﺎ ﻗﺒﻞ اﻟﺘﺮﻛﻴﺐ‬
and pre-installation work plans.

2. A complete list of numbers, types, brands, models and ‫ ﻗﺎﺋﻤﺔ ﻛﺎﻣﻠﺔ ﺑﺎﻷﻋﺪاد واﻷﺻﻨﺎف واﻟﻤﺎرﻛﺎت واﻟﻤﻮدﻳﻼت وﻛﺎﻓﺔ‬-2
all hardware accessories for each site. A copy of the ‫اﻟﻤﻠﺤﻘﺎت اﻟﺨﺎﺻﺔ ﺑﺎﻷﺟﻬﺰة ﻟﻜﻞ ﻣﻮﻗﻊ وﻳﺘﻢ ﺗﺴﻠﻴﻢ ﻧﺴﺨﺔ ﻣﻨﻬﺎ‬
same shall be delivered to the Engineering ‫إﻟﻰ اﻹدارة اﻟﻬﻨﺪﺳﻴﺔ ﻓﻲ اﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ‬
Department in the Member States and the
participating parties.

3. Two (2) copies of the operating instructions from the ‫ ﻧﺴﺨﺘﺎن ﻣﻦ ﺗﻌﻠﻴﻤﺎت اﻟﺘﺸﻐﻴﻞ ﻣﻦ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻟﻜﻞ ﺑﻨﺪ ﻣﻦ‬-3
manufacturer for each item in Arabic and English, two ‫ وﻧﺴﺨﺘﺎن ﻣﻦ ﻛﺘﻴﺐ اﻟﺼﻴﺎﻧﺔ‬،‫اﻷﺟﻬﺰة ﺑﺎﻟﻠﻐﺘﻴﻦ اﻟﻌﺮﺑﻴﺔ واﻹﻧﺠﻠﻴﺰﻳﺔ‬
copies of the maintenance manual and the spare parts ‫وﻗﻮاﺋﻢ ﻗﻄﻊ اﻟﻐﻴﺎر ﻣﻦ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻟﻜﻞ ﺑﻨﺪ ﻣﻦ اﻷﺟﻬﺰة‬
lists from the manufacturer for each item in Arabic ‫ﺑﺎﻟﻠﻐﺘﻴﻦ اﻟﻌﺮﺑﻴﺔ واﻹﻧﺠﻠﻴﺰﻳﺔ‬
and English.

4. A full set of operation manuals and user guide with ‫ ﻣﺠﻤﻮﻋﺔ ﻛﺎﻣﻠﺔ ﻟﻜﺘﻴﺒﺎت اﻟﺘﺸﻐﻴﻞ ودﻟﻴﻞ اﻟﻤﺴﺘﺨﺪم ﻣﻊ ﻛﻞ ﺟﻬﺎز‬-4
each device or the ancillary devices, including manuals ‫أو ﻣﻊ أﺟﻬﺰة رﻓﻊ ﻣﺴﺘﻮى ﻛﻔﺎءة اﻟﺠﻬﺎز ﺑﻤﺎ ﻓﻲ ذﻟﻚ ﻛﺘﻴﺒﺎت ﺑﺮاﻣﺞ‬
of computer software whenever applicable, and any ‫اﻟﺤﺎﺳﺐ اﻵﻟﻲ ﺣﻴﺜﻤﺎ اﻧﻄﺒﻖ ذﻟﻚ وأي ﻣﻮاد ﻣﻄﺒﻮﻋﺔ أو أﺷﺮﻃﺔ‬
other printed materials or CDs related to the devices ‫ﺳﻮاء ﻣﻄﺒﻮﻋﺔ أو ﻣﺮﺋﻴﺔ ﺧﺎﺻﺔ ﺑﺎﻟﺘﺪرﻳﺐ أو ﺗﻌﻠﻴﻢ‬
ً ‫ﻣﺘﻮﻓﺮة ﻣﻊ اﻟﺠﻬﺎز‬
and the user training of the device (such as video ‫اﻟﻤﺴﺘﺨﺪﻣﻴﻦ ﻟﻠﺠﻬﺎز )ﻣﺜﻞ أﺷﺮط اﻟﻔﻴﺪﻳﻮ واﻷﻗﺮاص اﻟﻤﻀﻐﻮﻃﺔ‬
tapes, CDs, and DVDs). (‫وأﺷﺮﻃﺔ دﻳﻔﻴﺪي‬

5. All electrical and electronic circuit schemas must be ‫ ﻳﺠﺐ أن ﺗﻜﻮن ﺟﻤﻴﻊ اﻟﺮﺳﻮﻣﺎت اﻟﺘﺨﻄﻴﻄﻴﺔ ﻟﻠﺪواﺋﺮ اﻟﻜﻬﺮﺑﺎﺋﻴﺔ‬-5
original not copy. ‫واﻹﻟﻜﺘﺮوﻧﻴﺔ أﺻﻠﻴﺔ وﻟﻴﺴﺖ ﺻﻮرة‬

6. A full set of maintenance and operation manuals ‫ ﻣﺠﻤﻮﻋﺔ ﻛﺎﻣﻠﺔ ﻣﻦ ﻛﺘﻴﺒﺎت اﻟﺼﻴﺎﻧﺔ واﻟﺘﺸﻐﻴﻞ )ﻣﻮاد ﻣﻄﺒﻮﻋﺔ‬-6
(printed and electronic form if any) for each supplied ‫وﻧﺴﺨﺔ إﻟﻜﺘﺮوﻧﻴﺔ إذا ﻛﺎن ذﻟﻚ ﻣﺘﻮﻓﺮ( ﻟﻜﻞ ﺟﻬﺎز ﻳﺘﻢ ﺗﻮرﻳﺪه أو‬
or upgraded device in order to raise the devices' ‫ﺗﺮﻗﻴﺘﻪ ﻟﺮﻓﻊ ﻣﺴﺘﻮى ﻛﻔﺎءة اﻷﺟﻬﺰة إﺿﺎﻓﺔ ﻟﻠﻤﺨﻄﻄﺎت اﻟﻜﻬﺮﺑﺎﺋﻴﺔ‬
efficiency, in addition to the electrical and ‫واﻟﻤﻴﻜﺎﻧﻴﻜﻴﺔ واﻟﻐﺎزﻳﺔ وﻣﺎ ﻳﺘﻌﻠﻖ ﺑﺎﻟﻬﻮاء أو اﻟﺴﻮاﺋﻞ أو اﻟﺒﺼﺮﻳﺎت‬
mechanical plans and every matter related to the ‫ودﻟﻴﻞ اﻛﺘﺸﺎف اﻷﻋﻄﺎل واﻟﺼﻴﺎﻧﺔ واﻹﺻﻼح اﻟﺘﻲ ﺗﻢ ﺗﻮﻓﻴﺮﻫﺎ ﻣﻦ‬
gas, air, and liquids used in such device. Faults ‫ﻗﺒﻞ ﺻﺎﻧﻊ اﻟﺠﻬﺎز وإذا ﺗﻄﻠﺐ اﻷﻣﺮ ﺳﻴﻘﻮم ﻣﻤﺜﻞ اﻟﺠﻬﺔ اﻟﻤﺸﺎرﻛﺔ‬
discovery and troubleshooting manuals shall also be ‫ﺑﺘﻮﻗﻴﻊ اﺗﻔﺎﻗﻴﺔ ﻋﺪم إﻓﺸﺎء ﻣﻌﻠﻮﻣﺎت ﻣﻊ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻣﻦ‬
provided as issued by the manufacturer. If the need ‫أﺟﻞ اﻟﺤﺼﻮل ﻋﻠﻰ ﻣﻮاد اﻟﺼﻴﺎﻧﺔ ﻣﻦ ﻫﺬا اﻟﻨﻮع‬
arise, the representative of the Participating Party
shall sign a Non-Disclosure Agreement with the

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 19 of 21
manufacturer in order to procure maintenance
materials of such kind.

7. Manufacturer shall provide all available information ‫ ﺗﻠﺘﺰم اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﺑﺘﻮﻓﻴﺮ ﺟﻤﻴﻊ اﻟﻤﻌﻠﻮﻣﺎت اﻟﻤﺘﻮﻓﺮة ﻟﻬﺎ ﻣﻦ‬-7
such as books, video tapes, CDs and training websites ‫ﻛﺘﺐ وأﺷﺮﻃﺔ ﻓﻴﺪﻳﻮ وأﻗﺮاص ﻛﻤﺒﻴﻮﺗﺮ ﻣﻀﻐﻮﻃﺔ وﻣﻮاﻗﻊ ﺗﺪرﻳﺐ‬
for the company on the internet in order to assist the ‫ﻟﻠﺸﺮﻛﺔ ﻋﻠﻰ اﻟﻮﻳﺐ وﺧﻼﻓﻪ اﻟﺘﻲ ﺗﺴﺎﻋﺪ اﻟﻌﺎﻣﻠﻴﻦ ﻋﻠﻰ ﺗﺸﻐﻴﻞ‬
personnel to operate the devices and have the full ‫اﻷﺟﻬﺰة واﻻﺳﺘﻔﺎدة اﻟﻜﺎﻣﻠﺔ ﻣﻦ إﻣﻜﺎﻧﻴﺎﺗﻬﺎ‬
advantage from them.

8. (5) copies of CDs containing the Service Manual and (Service Manual) ‫ ﻋﺪد ﺧﻤﺲ ﻧﺴﺦ ﻋﻠﻰ أﻗﺮاص ﺻﻠﺒﺔ ﺗﺤﺘﻮي‬-8
full information on how to maintain the device. This ً
‫وأﻳﻀﺎ ﻳﺸﻤﻞ ذﻟﻚ ﺟﺪول‬ ‫ﺑﻴﺎﻧﺎت ﻛﺎﻣﻠﺔ ﻟﺘﻌﻠﻴﻤﺎت اﻟﺼﻴﺎﻧﺔ ﻟﻠﺠﻬﺎز‬
must include also a separate and detailed schedule for ‫ﺧﺎص وﻣﻔﺼﻞ ﻟﻠﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ ﻟﻠﺠﻬﺎز ﻳﻮﺿﺢ ﻓﻴﻪ إﺟﺮاءات‬
preventive maintenance showing the procedures of ‫اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ اﻟﻴﻮﻣﻴﺔ واﻷﺳﺒﻮﻋﻴﺔ واﻟﺸﻬﺮﻳﺔ واﻟﺮﺑﻊ ﺳﻨﻮﻳﺔ‬
daily, weekly, monthly, quarterly, semi-annual and ‫واﻟﻨﺼﻒ ﺳﻨﻮﻳﺔ واﻟﺴﻨﻮﻳﺔ‬
annual preventative maintenance.

9. These copies shall be officially distributed to the ‫ ﻳﺘﻢ ﺗﻮزﻳﻊ ﻫﺬه اﻟﻨﺴﺦ ﺑﺸﻜﻞ رﺳﻤﻲ ﻟﻠﺠﻬﺎت اﻟﻤﻌﻨﻴﺔ ﺣﺴﺐ ﻃﻠﺐ‬-9
concerned bodies as requested by the Participating ‫اﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ‬
Parties.

Tests of X-Ray Devices :‫اﺧﺘﺒﺎرات أﺟﻬﺰة اﻷﺷﻌﺔ‬


1. Manufacturer shall make sure that acceptance tests ‫ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ ﻋﻤﻞ اﺧﺘﺒﺎرات ﻗﺒﻮل ﺗﻮﻛﻴﺪ ﻟﻠﺠﻮدة‬ -1
related to quality assurance are performed by a third
‫اﻟﻨﻮﻋﻴﺔ ﻻﺧﺘﺒﺎرات ﻗﻴﺎس اﻟﺘﺴﺮب اﻹﺷﻌﺎﻋﻲ ﻷﺟﻬﺰة اﻷﺷﻌﺔ أو‬
party company wholly independent of the
ً
‫ﺗﻤﺎﻣﺎ ﻋﻦ‬ ‫أي أﺟﻬﺰة ﻟﻬﺎ ﻧﺸﺎط إﺷﻌﺎﻋﻲ ﻣﻦ ﻃﺮف ﺛﺎﻟﺚ ﻣﺴﺘﻘﻞ‬
manufacturer or its representative, specialized in the
field and licensed by the concerned authorities in the ‫ﺮﺧﺺ‬
ّ ‫وﻣ‬
ُ ‫اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ أو ﻣﻦ ﻳﻤﺜﻠﻬﺎ وﻣﺘﺨﺼﺺ ﻓﻲ اﻟﻤﺠﺎل‬
Member States and participating parties. These ‫ﻣﻦ اﻟﺠﻬﺎت اﻟﺮﺳﻤﻴﺔ ﻓﻲ اﻟﺪول اﻷﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ‬
acceptance tests shall include the measuring radiation
leakage of radiology devices or any radiology
equipment.

2. All the devices listed in the Bills of Quantities of the ‫ ﺟﻤﻴﻊ اﻷﺟﻬﺰة اﻟﻤﺬﻛﻮرة ﻓﻲ ﺟﺪول اﻟﻜﻤﻴﺎت ﻟﻤﺠﻤﻮﻋﺔ اﻷﺷﻌﺔ‬-1
Radiology Group are mandatory after determining the ‫ﺗﻌﺘﺒﺮ إﻟﺰاﻣﻴﺔ ﺑﻌﺪ ﻣﻌﺮﻓﺔ أﻧﻮاع اﻷﺟﻬﺰة ورﺑﻄﻬﺎ ﺑﻨﻈﺎم اﻟﺒﺎﻛﺲ‬
types of devices and connecting them to the PACs ‫( ﻣﻊ ﺗﺤﺪﻳﺚ اﻟﻨﻈﺎم ﺣﺴﺐ اﻟﺤﺎﺟﺔ أو ﺣﺴﺐ ﻃﻠﺐ‬Web)
system and updating the system according to need or ‫اﻟﻤﺴﺘﺸﻔﻰ ﺧﻼل ﺳﻨﻮات اﻟﻀﻤﺎن وإﺣﻀﺎر ﺷﻬﺎدة ﺑﺎﻟﺴﻤﺎح‬
according to the request of the hospital during the ‫ﺑﺄي ﻧﻈﺎم ﺑﺎﻛﺲ دون ﺗﻜﻠﻔﺔ ﻋﻠﻰ اﻟﻤﺴﺘﺸﻔﻰ‬
years of warranty and provide a certificate to allow
any system of PACs system without any cost on the
hospital.
Maintenance for Diagnostic X-Ray Devices: :‫اﻟﺼﻴﺎﻧﺔ ﻷﺟﻬﺰة اﻷﺷﻌﺔ اﻟﺘﺼﻮﻳﺮﻳﺔ‬
1. When the MRI and CT devices experience failure for ‫( أﻛﺜﺮ ﻣﻦ اﻟﻔﺘﺮة اﻟﻤﺴﻤﻮح‬MRI.CT) ‫ ﻓﻲ ﺣﺎل ﺗﻌﻄﻞ أﺟﻬﺰة‬-1
more than the allowed period (48 hours), patients ‫ ﺳﺎﻋﺔ ﻳﺘﻢ إرﺳﺎل اﻟﻤﺮﺿﻰ إﻟﻰ‬48 ‫ﺑﻬﺎ ﻋﻠﻰ اﻟﻌﻄﻞ وﻫﻲ‬

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 20 of 21
shall be referred to the private hospitals at the ‫اﻟﻤﺴﺘﺸﻔﻴﺎت اﻟﺨﺎﺻﺔ وﻋﻠﻰ ﺣﺴﺎب اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ‬
expense of the manufacturer and the costs thereof ً
‫ وﻓﻲ ﺣﺎﻟﺔ ﻋﺪم اﻟﻘﻴﺎم ﺑﺄﻋﻤﺎل‬،‫وﺣﺴﻤﺎ ﻣﻦ ﻣﺴﺘﺤﻘﺎﺗﻬﺎ‬
shall be deducted from its dues. In case the ‫اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ ﻓﻲ ﻣﻮاﻋﻴﺪﻫﺎ اﻟﻤﺤﺪدة ﻳﺘﻢ ﺗﻄﺒﻴﻖ‬
maintenance works are not performed on time, the ً
.‫ﺣﺴﻤﺎ ﻣﻦ ﻣﺴﺘﺤﻘﺎت اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ‬ ‫ﻏﺮاﻣﺎت اﻟﺘﻘﺼﻴﺮ‬
default fines shall be imposed and deducted from the ‫ﺗﻄﺒﻖ اﻟﺤﺴﻤﻴﺎت ﻓﻲ ﺣﺎﻟﺔ اﻟﺘﺄﺧﻴﺮ ﻓﻲ اﻹﺻﻼح أو اﻟﺘﻘﺼﻴﺮ‬
ّ -2
manufacturer's dues. ‫ﻓﻲ أﻋﻤﺎل اﻟﺼﻴﺎﻧﺔ اﻟﻮﻗﺎﺋﻴﺔ ﺣﺴﺐ ﺑﻨﺪ ﻏﺮاﻣﺎت اﻟﺘﻘﺼﻴﺮ‬
2. Deductions in case of delay in performing repair and .‫ﻓﻲ اﻟﺼﻴﺎﻧﺔ ﺧﻼل ﻓﺘﺮة اﻟﻀﻤﺎن‬
maintenance works shall be applied in accordance
with the Maintenance Default Fines Clause related to
maintenance during the warranty period.

Supply Period: :‫ﻣﺪة اﻟﺘﻮرﻳﺪ‬


1. Manufacturer shall provide services of supplying, ‫ ﻋﻠﻰ اﻟﺸﺮﻛﺔ اﻟﺼﺎﻧﻌﺔ اﻟﻘﻴﺎم ﺑﻌﻤﻠﻴﺔ اﻟﺘﻮرﻳﺪ واﻟﺘﺮﻛﻴﺐ واﻟﺘﺸﻐﻴﻞ‬-1
installation, operation and training within 6-8
‫ أﺷﻬﺮ ﻣﻦ ﺗﺎرﻳﺦ اﺳﺘﻼم اﻟﻤﻮﻗﻊ ﻋﻠﻰ ان‬8 ‫ اﻟﻰ‬6 ‫واﻟﺘﺪرﻳﺐ ﻣﻦ‬
months from the date of receipt of the site,
‫ﻳﺘﻢ اﺳﺘﻼم اﻟﻤﻮﻗﻊ ﺧﻼل ﺷﻬﺮﻳﻦ ﻣﻦ ﺗﺎرﻳﺦ اﻻﺷﻌﺎر ﺑﺎﻟﺘﺮﺳﻴﺔ‬
provided that the site shall be handed over within
two months from the date of award letter.

2. After being awarded, the concerned bidder shall ‫ﻋﻠﻴﻪ‬ ‫اﻟﺘﺮﺳﻴﺔ‬ ‫ﻋﻨﺪ‬ ‫ﺑﺎﻟﺘﻮرﻳﺪ‬ ‫اﻟﻌﺮض‬ ‫ﻣﻘﺪم‬ ‫ ﻳﻠﺘﺰم‬-2
supply the relevant items to hospitals/centers ‫اﻟﻤﺮاﻛﺰ اﻟﻤﻮﺿﺤﺔ ﺑﺎﻟﺘﻮزﻳﻊ اﻟﻤﺤﺪد ﻣﻦ اﻟﺪول‬/‫ﻟﻠﻤﺴﺘﺸﻔﻴﺎت‬
specified in the distribution scheme determined by ‫اﻻﻋﻀﺎء واﻟﺠﻬﺎت اﻟﻤﺸﺎرﻛﺔ‬
the Member States and Participating Parties.

‫اﻟﺸﺮوط اﻟﺨﺎﺻﺔ وﺷﺮوط اﻟﺘﻮرﻳﺪ ﻟﻤﻨﺎﻗﺼﺔ اﻷﺟﻬﺰة اﻟﻄﺒﻴﺔ‬


Special Conditions & Terms of Supply for Tender of Medical Devices
Page 21 of 21

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