Ophthalmic optics - Ophthalmic viscosurgical devices
1 Scope
This standard specifies requirements with regard to safety for the intended performance, design attributes, design evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of ophthalmic viscosurgical devices.
This standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of substances with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T16886.1-2011; ISO 10993-1: 2009, IDT)
GB/T 16886.2 Biological evaluation of medical devices - Part 2: Animal welfare requirements (GB/T 16886.2-2011; ISO 10993-2: 2009, IDT)
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (GB/T 16886.5-2003; ISO 10993-5: 1999, IDT)
GB/T 16886.6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (GB/T 16886.6-1997; ISO 10993-6: 1994, IDT)
GB/T 16886.9 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (GB/T 16886.9-2001; ISO 10993-9: 1999, IDT)
GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (GB/T 16886.10-2005; ISO 10993-10: 2002, IDT)
GB/T 16886.16 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (GB/T 16886.16-2003; ISO 10993-16: 1997, IDT)
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005; ISO 11607: 2003, IDT)
YY/T 0297 Clinical investigation of medical devices (YY/T 0297-1997; ISO 14155: 1996, IDT)
YY/T 0316 Medical devices - Application of risk management to medical devices (YY/T 0316-2008; ISO 14971: 2007, IDT)
YY/T 0466.1 Medical devices- Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (YY/T 0466.1-2009; ISO 15223-1: 2007, IDT)
YY/T 0640 Non-active surgical implants - General requirements (YY/T 0640-2008; ISO 14630: 2005, IDT)
YY/T 0771.1-2009 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1: 2007, IDT)
YY/T 0771.2-2009 Medical devices utilizing animal tissues and their derivatives - Part 2:Controls on sourcing, collection and handling (ISO 22442-2: 2007, IDT)
YY/T 0771.3-2009 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents (ISO 22442-3: 2007, IDT)
Pharmacopoeia of the People’s Republic of China (2010 Edition, Volume II)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
complex viscosity
η*＝η′－i·η″
viscosity consisting of a viscous η′ and an elastic η′′ component where i is an imaginary number defined by
3.2
absolute complex viscosity
absolute value of complex viscosity (3.1)
Note: Absolute complex viscosity is expressed in Pa·s.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design characteristics
6 Design evaluation
7 Sterilization
8 Product stability
9 Integrity and performance of delivery system
10 Packaging
11 Information to be supplied by the manufacturer
Annex A (Normative) Intraocular implantation test
Annex B (Informative) Clinical evaluation
Annex C (Informative) Comparison between this standard and ISO 15798: 2010 in clause/subclause number
Annex D (Informative) Technical differences between this standard and ISO 15798: 2010 and their reasons
Ophthalmic optics - Ophthalmic viscosurgical devices
1 Scope
This standard specifies requirements with regard to safety for the intended performance, design attributes, design evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of ophthalmic viscosurgical devices.
This standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of substances with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T16886.1-2011; ISO 10993-1: 2009, IDT)
GB/T 16886.2 Biological evaluation of medical devices - Part 2: Animal welfare requirements (GB/T 16886.2-2011; ISO 10993-2: 2009, IDT)
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (GB/T 16886.5-2003; ISO 10993-5: 1999, IDT)
GB/T 16886.6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (GB/T 16886.6-1997; ISO 10993-6: 1994, IDT)
GB/T 16886.9 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (GB/T 16886.9-2001; ISO 10993-9: 1999, IDT)
GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (GB/T 16886.10-2005; ISO 10993-10: 2002, IDT)
GB/T 16886.16 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (GB/T 16886.16-2003; ISO 10993-16: 1997, IDT)
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005; ISO 11607: 2003, IDT)
YY/T 0297 Clinical investigation of medical devices (YY/T 0297-1997; ISO 14155: 1996, IDT)
YY/T 0316 Medical devices - Application of risk management to medical devices (YY/T 0316-2008; ISO 14971: 2007, IDT)
YY/T 0466.1 Medical devices- Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (YY/T 0466.1-2009; ISO 15223-1: 2007, IDT)
YY/T 0640 Non-active surgical implants - General requirements (YY/T 0640-2008; ISO 14630: 2005, IDT)
YY/T 0771.1-2009 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1: 2007, IDT)
YY/T 0771.2-2009 Medical devices utilizing animal tissues and their derivatives - Part 2:Controls on sourcing, collection and handling (ISO 22442-2: 2007, IDT)
YY/T 0771.3-2009 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents (ISO 22442-3: 2007, IDT)
Pharmacopoeia of the People’s Republic of China (2010 Edition, Volume II)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
complex viscosity
η*＝η′－i·η″
viscosity consisting of a viscous η′ and an elastic η′′ component where i is an imaginary number defined by
3.2
absolute complex viscosity
absolute value of complex viscosity (3.1)
Note: Absolute complex viscosity is expressed in Pa·s.
Contents of YY 0861-2011
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design characteristics
6 Design evaluation
7 Sterilization
8 Product stability
9 Integrity and performance of delivery system
10 Packaging
11 Information to be supplied by the manufacturer
Annex A (Normative) Intraocular implantation test
Annex B (Informative) Clinical evaluation
Annex C (Informative) Comparison between this standard and ISO 15798: 2010 in clause/subclause number
Annex D (Informative) Technical differences between this standard and ISO 15798: 2010 and their reasons
