Home Cart Quotation About-Us
www.ChineseStandard.net
SEARCH

YY/T 1777-2021 PDF English

US$680.00 · In stock · Download in 9 seconds
YY/T 1777-2021: Male condoms - Requirements and test methods for condoms made from synthetic materials
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid
Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
YY/T 1777-2021680 Add to Cart Auto, 9 seconds. Male condoms - Requirements and test methods for condoms made from synthetic materials Valid

Similar standards

YY/T 1783   YY/T 1797   YY/T 1704.2   YY/T 1769   

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.
Image 1     Image 2     Image 3     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of English version of YY/T 1777-2021 be delivered?Answer: The full copy PDF of English version of YY/T 1777-2021 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.

Question 2: Can I share the purchased PDF of YY/T 1777-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1777-2021_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 1777-2021 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.

How to buy and download a true PDF of English version of YY/T 1777-2021?

A step-by-step guide to download PDF of YY/T 1777-2021_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 1777-2021".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3    Steps 4~6    Step 7    Step 8    Step 9