YY/T 0616.2-2016Medical glove for single use - Part 2: Requirements and testing for shelf life determination (English PDF)

Foreword

YY/T 0616 "One-time use of medical gloves" is divided into two parts.

- Part 1. Biology evaluation requirements and testing;

- Part 2. Requirements and tests for determining shelf life. This part is part 2 of YY/T 0616.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This section refers to EN 455-4.:2009 "Disposable medical gloves Part 4. Requirements and tests for determining shelf life".

Introduction

Medical gloves are expected to be used as a barrier to infection. To ensure its effectiveness, the gloves are necessary for hand, impermeable and adequate Of the physical strength, so that it does not occur in the use of failure. The national standard for medical gloves 1) gives these requirements.

This standard requires manufacturers to conduct stability tests prior to product launch to estimate the shelf life of any new or technically improved gloves Life, and at the same time the actual time stability study. The actual time stability test can be seen as requiring the manufacturer to supervise the post-market product The contents of the governor. These requirements are expected to ensure that the manufacturer has sufficient data to support the declaration of the shelf life of its products before listing Submitted to the regulatory body for review.

1) These standards include GB 7543, GB 10213, GB 24786 and GB 24787 and so on.

1 Scope

YY/T 0616 this part of the provisions of the disposable use of gloves shelf life requirements. Also specify the label and the test used Method related to the disclosure of information requirements.

This section applies to existing, new and designed products with significant changes. It is reasonable to have an existing design that does not have available aging data Of the time period to produce data.

This section does not specify the bulk size. Need to pay attention to the bulk of the difficulties in circulation and control. The maximum number of recommended production batches The amount of 500000.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 19633 (all parts) final sterilization of medical equipment packaging

3 Terms and definitions

The following terms and definitions apply to this document.