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YY/T 1777-2021 English PDF (YYT1777-2021)

YY/T 1777-2021 English PDF (YYT1777-2021)

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YY/T 1777-2021: Male condoms - Requirements and test methods for condoms made from synthetic materials

YY/T 1777-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.200
C 36
YY/T 1777-2021 / ISO 23409:2011
Male Condoms - Requirements and Test Methods for
Condoms Made from Synthetic Materials
(ISO 23409:2011, IDT)
ISSUED ON: SEPTEMBER 6, 2021
IMPLEMENTED ON: SEPTEMBER 1, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
Introduction ... 6
1 Scope ... 7
2 Normative References ... 7
3 Terms and Definitions ... 8
4 Quality Verification ... 10
5 Lot Size ... 11
6 Biocompatibility ... 11
7 Product Claims ... 11
8 Design ... 12
9 Preclinical Evaluation ... 13
10 Clinical (human use) Investigations ... 13
11 Bursting Volume and Pressure ... 14
12 Freedom from Holes ... 15
13 Stability and Shelf-life ... 15
14 Visible Defects ... 16
15 Package Integrity for Individual Container ... 16
16 Packaging and Labelling ... 16
17 Data Sheet and Test Report ... 20
Appendix A (normative) Sampling Plans Intended for Assessing Compliance of a Continuing Series of Lots with Sufficient Number to Allow the Switching Rules to be Applied ... 22
Appendix B (informative) Sampling Plans that are Intended for Assessing the Compliance of Isolated Lots ... 24
Appendix C (normative) Determination of Total Lubricant for Condoms in Individual Containers ... 26
Appendix D (normative) Determination of Length ... 28
Appendix E (normative) Determination of Width ... 30
Appendix F (normative) Determination of Thickness ... 31
Appendix G (informative) Determination of Barrier Properties Using the Bacteriophage Method ... 33
Appendix H (normative) Determination of the Bursting Volume and Pressure ... 38 Appendix I (informative) Calibration of Air Inflation Equipment for Determination of Burst Volume and Pressure ... 41
Appendix J (normative) Testing for Holes ... 45
Appendix K (normative) Determination of Shelf-life by Real-time Stability Tests ... 51 Appendix L (informative) Guidance on Conducting and Analyzing Ageing Studies .. 53 Appendix M (normative) Tests for Individual Container Integrity ... 56
Appendix N (informative) Over Treatment for Condoms Made from Synthetic Materials ... 58
Bibliography ... 59
Foreword
This Standard was drafted in accordance with the rules provided in GB/T 1.1-2009. This Standard adopts the translation method in the identical adoption of ISO 23409:2011 Male Condoms - Requirements and Test Methods for Condoms Made from Synthetic Materials. The Chinese documents that have consistent correspondence with the international documents normatively cited in this Standard are as follows:
---GB/T 2828.1-2012 Sampling Procedures for Inspection by Attributes - Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection (ISO 2859-1:1999, IDT)
---GB/T 7544-2019 Natural Rubber Latex Male Condoms - Requirements and Test Methods (ISO 4074:2015, IDT)
---GB/T 16886.1-2011 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process (ISO 10993-1:2009, IDT)
---GB/T 16886.5-2017 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity (ISO 10993-5:2009, IDT)
---GB/T 16886.10-2017 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization (ISO 10993-10:2010, IDT)
---YY/T 0297-1997 Clinical Investigation of Medical Devices (idt ISO 14155:1996) ---YY/T 0316 Medical Devices - Application of Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971:2007, corrected version, IDT)
---YY/T 0466 Medical Devices – Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied (all parts) [ISO 15223 (all parts)] Please be noted that certain content of this document may involve patents. The institution issuing this document does not undertake the responsibility of identifying these patents. This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of National Technical Committee on Mechanical Contraceptives of Standardization Administration of China (SAC/TC 169). The drafting organizations of this Standard: Wuhan Jissbon Hygiene Products Co., Ltd.; Guangzhou Daming United Rubber Products Co., Ltd.; Shanghai Medical Devices Testing Institute.
The main drafters of this Standard: Ren Juan, Chen Weide, Yao Tianping, Zhang Jing, Luo Male Condoms - Requirements and Test Methods for
Condoms Made from Synthetic Materials
1 Scope
This Standard specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.
ISO 2859-1, Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 4074, Natural latex rubber condoms - Requirements and test methods
ISO/TR 8550 (all parts), Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots
ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 14155, Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14971, Medical devices - Application of risk management to medical devices ISO 15223 (all parts), Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied
ISO 16037, Rubber condoms for clinical trials - Measurement of physical properties 9 Preclinical Evaluation
A risk analysis of the product shall be conducted in accordance with ISO 14971. The analysis shall identify safety and efficacy concerns, and shall address at least the areas where the risks are in excess of those encountered with natural rubber latex condoms conforming to ISO 4074. The barrier properties of the condom shall be established by viral penetration studies using simulated use conditions and a suitable surrogate virus, e.g. bacteriophage phiX 174. Viral penetration properties shall be compared with those of a latex condom that meets the requirements of ISO 4074. A suitable procedure for conducting these studies is given in Annex G. The number of test condoms exhibiting leakage of virus suspension fluid above the detection limit of 2  10−6 mL should not be significantly worse than for the control latex condom. Appropriate statistical procedures may be used to analyze the results using a 95 % confidence interval.
Biocompatibility for the finished product and its components shall be established in accordance with the relevant clauses of ISO 10993-1, ISO 10993-5, and ISO 10993-10. Condoms are a surface device with repeated contact with mucosa and possibly compromised tissue surfaces. The tests shall indicate whether the device produces cytotoxicity, sensitization, or mucosal irritation. It is possible for additional testing, e.g. for systemic toxicity in accordance with ISO 10993-11, to be required, depending upon the nature of the materials used or to meet local regulatory requirements. If there is a likelihood of systemic absorption of any components or residuals, mutagenicity testing shall be performed. Regulatory bodies can require the results to be interpreted by a qualified toxicologist or suitably qualified scientist. The biological assessment report shall justify that the product is safe under normal conditions of use. All data generated in these investigations shall be available to regulatory authorities on request. The manufacturer shall obtain, and make available on request from regulatory authorities, toxicity data on all the additives and residual monomers, residual solvents and known impurities resulting from the manufacture of the condom.
Suitable material safety data sheets are to be supplied as requested for materials used in the manufacture of products in compliance with this Standard.
10 Clinical (human use) Investigations
The manufacturer shall conduct a randomized controlled clinical investigation comparing the synthetic condom to a control condom made from natural rubber latex.
a) Clinical investigations in humans shall be conducted in accordance with local regulatory requirements, as well as ISO 14155.
b) The clinical failure rate (combined slippage and breakage rates) of the synthetic condom shall be non-inferior to the clinical failure rate of the control condom made

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