YY/T 0616.3-2018Medical gloves for single use - Part 3: Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions (English PDF)
一次性使用医用手套 第3部分：用仓贮中的成品手套确定实际时间失效日期的方法
This is a limited preview
Buy now to download the full PDF (25 pages)
Need quotation for your management?
Get a formal quotation for YY/T 0616.3-2018 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
November 7, 2018
Implementation date
November 1, 2019
Scope
YY/T 0616.3-2018 is the English-translated version of 一次性使用医用手套 第3部分：用仓贮中的成品手套确定实际时间失效日期的方法.
YY/T 0616.3-2018 is the Chinese pharmaceutical industry standard that sets out how the shelf life of medical gloves in their final packaging is determined under typical storage conditions.
It is the third part of the YY/T 0616 series and covers the design of the study: the batches, the storage conditions for real-time and accelerated ageing, the intervals and the properties to be measured, among them the tensile properties and freedom from holes, and the way the data support the expiry date claimed.
It applies to all surgical and examination gloves, of natural rubber latex or synthetic material. Issued on 7 November 2018, it has applied since 1 November 2019.
Found what you need?
Document preview — YY/T 0616.3-2018
National Standard of the People's Republic of China
- ICS
- 11.140
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
YY/T 0616 "Disposable Medical Gloves" consists of the following parts.
--- Part 1. Biological evaluation requirements and tests;
--- Part 2. Determination of shelf life requirements and tests;
--- Part 3. Method of determining the actual time lapse date using finished gloves in storage. This part is the third part of YY/T 0616.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This section of YY/T 0616 specifies the shelves for medical gloves used to determine their final packaging and stored under typical storage conditions. Life study design.
This section applies to all surgical and examination gloves made of synthetic or natural latex.
Note. These gloves are already on the market at the time of publication of this standard. There is no actual time aging data available before, and as a final product in a typical warehouse At least 12 months have been stored under the conditions. This section describes how to obtain the actual stock of finished gloves (including gloves that may no longer be manufactured).
Time aging data to verify the estimated expiration date. Accelerated aging of shelf life is described in YY/T 0616.2.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 2828.1. Sampling procedures for sampling by sampling - Part 1. Batch-to-batch sampling plan, searched by AQL
GB 7543-2006 Disposable sterile rubber surgical gloves
GB 10213-2006 disposable medical rubber inspection gloves
GB/T 15171 soft package sealing performance test method Test methods for packaging of sterilized medical devices - Part 2. Sealing strength of soft barrier materials Test method for packaging of sterilized medical devices - Part 4. Determination of seal leakage of s.
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Date of manufacture
The date of the final processing step. For sterile products, the final treatment step is sterilization.
3.2 Storage medical gloves
Finished gloves that have been stored under storage for at least 12 months.
3.3 Actual time expiration date
The date of manufacture plus the date calculated for shelf life.
3.4 Shelf life
The period determined by the longest storage interval of the glove in storage (from the date of manufacture), there is data to confirm that the product meets the standard within the period The technical requirements given. This data should be derived using the test plans and methods given in this specification.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 0616.3-2018
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 15171-2025 — Test method for sealing performance of package
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
YY/T 0616.4-2018 — Medical glove for single use - Part 4: Test method for the puncturation resistance
Secure payment via Stripe
Payments accepted
YY/T 0616.3-2018
$85.00