YY/T 1777-2021Male condoms—Requirements and test methods for condoms made from synthetic materials (English PDF)

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.

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

3 Terms and Definitions

For the purposes of this document, the terms and definitions given in ISO 2859-1 and the following apply. number, or combination of numerals, symbols or letters, used by a manufacturer on consumer packages to identify uniquely the lot numbers of individual condoms contained in that package, and from which it is possible to trace those lots through all stages of manufacturing, packaging and distribution

4 Quality Verification

Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling plans are given in Annexes A and B.

5 Lot Size

The maximum individual lot size for production is 500,000.

Otherwise, this Standard does not specify the size of a lot, but it is possible for a purchaser to do so as part of the purchasing contract.

6 Biocompatibility

For any product which is new or which has undergone a significant change to the formulation or manufacturing process, biocompatibility assessments shall be conducted in accordance with ISO 10993-1.

7 Product Claims

Condoms meeting the requirements of this Standard can be used for contraceptive purposes and help protect against sexually transmitted infections. Manufacturers shall justify any additional claims made for their products.

8 Design

When tested according to the method given in Annex D, taking 13 condoms from each lot, no individual measurement shall be below 160 mm.

If verification is required of the thickness of a condom, the thickness, determined in accordance with the method given in Annex F, shall be equal to the claimed thickness, subject to a tolerance of.

9 Preclinical Evaluation

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.