YY/T 1777-2021 PDF English
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YY/T 1777-2021: Male condoms - Requirements and test methods for condoms made from synthetic materials
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1777-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
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
Meifang, Wang Zewei.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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