LIST OF STANDARD / REFERENCES FOR MEDICAL DEVICES

N Product Classification Recognized Organization Title Number

o Standard Developing
by FDA Standard
1 Gown, Surgical Standard Specification for Surgical 6-448 ASTM F2407-20
Yes Gowns Intended for Use in Healthcare
US-FDA: Facilities
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2911 Standard Test Method for Resistance of 6-306 ASTM F1671/F1671M-
Materials Used in Protective Clothing to 13
Penetration by Blood-Borne Pathogens
Using Phi-X174 Bacteriophage
Penetration as a Test System
Standard Test Method for Resistance of 6-402 ASTM F1670/F1670M-
Materials Used in Protective Clothing to 17
Penetration by Synthetic Blood
Liquid barrier performance and 6-296 AAMI ANSI PB70:2012
classification of protective apparel and
drapes intended for use in health care
facilities
Processing of reusable surgical textiles 14-286 ANSI AAMI ST65:200
for use in health care facilities 8/(R)2018
2 Gown, Patient Processing of reusable surgical textiles 14-286 ANSI AAMI ST65:200
Yes for use in health care facilities 8/(R)2018
US-FDA:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2912
3 Gown, Isolation, Surgical Yes Standard Specification for Surgical 6-448 ASTM F2407-20
Gowns Intended for Use in Healthcare
US-FDA: Facilities
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2913 Standard Specification for Isolation 6-474 ASTM F3352-19
Gowns Intended for Use in Healthcare
Facilities
Standard Test Method for Resistance of 6-402 ASTM F1670/F1670M-

1
 LIST OF STANDARD / REFERENCES FOR MEDICAL DEVICES

N Product Classification Recognized Organization Title Number

o Standard Developing
by FDA Standard
Materials Used in Protective Clothing to 17
Penetration by Synthetic Blood
Processing of reusable surgical textiles 14-286 ANSI AAMI ST65:200
for use in health care facilities 8/(R)2018

4 Gown, Examination Yes Processing of reusable surgical textiles 14-286 ANSI AAMI ST65:200

for use in health care facilities 8/(R)2018
US-FDA:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2641

5 Non-Surgical Isolation Gown Yes Standard Specification for Isolation 6-474 ASTM F3352-19

Gowns Intended for Use in Healthcare
US-FDA: Facilities
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2928

6 Cover, Mattress (Medical Purposes) NA Specification for hospital bedding BS 5223-4:1976

mattress covers of polyurethane coated
US-FDA: nylon
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2652
7 Protective Clothing - Protective clothing - General EN ISO 13688:2013
(Coat) requirements
8 Drape, Surgical, Ent Yes Liquid barrier performance and 6-296 AAMI ANSI PB70:2012
classification of protective apparel and
US-FDA: drapes intended for use in health care
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2902 facilities
Lasers and laser-related equipment - 6-363 ISO 11810 Second
Test method and classification for the edition 2015-12-15
laser-resistance of surgical drapes
and/or patient-protective covers -

2
 LIST OF STANDARD / REFERENCES FOR MEDICAL DEVICES

N Product Classification Recognized Organization Title Number

o Standard Developing
by FDA Standard
Primary ignition, penetration, flame
spread and secondary ignition

9 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot Yes Liquid barrier performance and 6-296 AAMI ANSI PB70:2012
classification of protective apparel and
US-FDA: drapes intended for use in health care
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2903 facilities
Lasers and laser-related equipment - 6-363 ISO 11810 Second
Test method and classification for the edition 2015-12-15
laser-resistance of surgical drapes
and/or patient-protective covers -
Primary ignition, penetration, flame
spread and secondary ignition
10 Drape, Patient, Ophthalmic Yes Liquid barrier performance and 6-296 AAMI ANSI PB70:2012
classification of protective apparel and
drapes intended for use in health care
US-FDA: facilities
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2916 Lasers and laser-related equipment - 6-363 ISO 11810 Second
Test method and classification for the edition 2015-12-15
laser-resistance of surgical drapes
and/or patient-protective covers -
Primary ignition, penetration, flame
spread and secondary ignition
11 Drape, Surgical Yes Liquid barrier performance and 6-296 AAMI ANSI PB70:2012
classification of protective apparel and
US-FDA: drapes intended for use in health care
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2921 facilities

3
 LIST OF STANDARD / REFERENCES FOR MEDICAL DEVICES

N Product Classification Recognized Organization Title Number

o Standard Developing
by FDA Standard
Standard Test Method for Resistance of 6-306 ASTM F1671/F1671M-
Materials Used in Protective Clothing to 13
Penetration by Blood-Borne Pathogens
Using Phi-X174 Bacteriophage
Penetration as a Test System
Standard Test Method for Resistance of 6-402 ASTM F1670/F1670M-
Materials Used in Protective Clothing to 17
Penetration by Synthetic Blood
12 Cover, Barrier, Protective Yes Liquid barrier performance and 6-296 AAMI ANSI PB70:2012
classification of protective apparel and
US-FDA: drapes intended for use in health care
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=2925 facilities
Lasers and laser-related equipment - 6-363 ISO 11810 Second
Test method and classification for the edition 2015-12-15
laser-resistance of surgical drapes
and/or patient-protective covers -
Primary ignition, penetration, flame
spread and secondary ignition
13 Surgical Clothing and Drapes - Surgical clothing and drapes - CSN EN 13795-1
Requirements and test methods - Part
1: Surgical drapes and gowns
Surgical drapes, gowns and clean air ISO 22610:2018
suits, used as medical devices, for
patients, clinical staff and equipment —
Test method to determine the
resistance to wet bacterial penetration
SNI ISO 22610:2018

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 LIST OF STANDARD / REFERENCES FOR MEDICAL DEVICES

N Product Classification Recognized Organization Title Number

o Standard Developing
by FDA Standard
14 Pakaian Bedah - Pakaian dan kain bedah – Persyaratan SNI EN 13795-1:2019
dan metode uji – Bagian 1: Kain dan
gaun

15 Pakaian Bedah - Pakaian dan kain bedah – Persyaratan SNI EN 13795-2:2019

dan metode uji – Bagian 2: Baju ruang
steril