LIST OF DEVICES

Biocompatibility Classification
Issue No: 01
Dated:
16 December 2013

LIST OF DEVICES
Biocompatibility Classification
Device Name

Sterilization Tray
Silicone Mat/Holder
Ophthalmic Knives
Ophthalmic
Viscosurgical Device
Trypan Blue Device
Ophthalmic Strips
Surgical Drapes
Ophthalmic Cannula
Ophthalmic Sponges
Surgical Devices
Surgical Instruments
Surgical Kits

Category & Contact Site

Contact
Duration

Classification
Rule as per
Annex IX of
MDD

Class of
Medical
Device

NA

Rule 1

Class I

Does not come in contact with

patient
Does not come in contact with
patient
Surface Device; comes in
contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue

NA

Rule 1

Class I

limited
(< 24 hrs)
limited
(< 24 hrs)

Rule 6

Class IIa

Rule 6

Class IIa

Surface Device; comes in

contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue
Surface Device; comes in
contact with Ocular Tissue

limited
(< 24 hrs)
limited
(< 24 hrs)
limited
(< 24 hrs)
limited
(< 24 hrs)
limited
(< 24 hrs)
limited
(< 24 hrs)
limited
(< 24 hrs)
limited
(< 24 hrs)

Rule 6

Class IIa

Rule 5

Class IIa

Rule 5

Class IIa

Rule 6

Class IIa

Rule 6

Class IIa

Rule 5

Class IIa

Rule 6

Class IIa

Rule 6

Class IIa

Approved by: