YY/T 0698.1-2011Packaging materials for terminal sterilized medical devices - Part 1: Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods (English PDF)

Foreword

YY/T 0698 "terminally sterilized medical device packaging materials," including the following sections.

Co-extruded plastic film plastic packaging requirements and test methods;. --- Part 1 --- Part 2. Sterilization wrap material requirements and test methods;

--- Part 3. paper (YY/T 0698.4 forth), a combination of bags and coils (YY/T 0698.5 forth) to produce paper Sum Test methods;

--- Part 4. Paper bags - Requirements and test methods;

--- Part 5. ziplock and roll and sealing requirements and test methods for paper and plastic film in combination;

--- Part 6. Paper for low temperature sterilized production requirements and test methods for the sterile barrier system procedures or radiation sterilization;

--- Part 7. ethylene oxide for medical or radiation sterilization sealable sterile barrier systems used in the production of paper coating requirements and tests method;

--- Part 8. steam sterilizers repeatability requirements and test methods for sterilizing containers;

--- Part 9. combination sealable bags, and the cover sheet material production without nonwovens requirements and test methods for coating polyolefin;

--- Part 10. combination sealable bags, and the cover sheet material production nonwovens requirements and test methods for coating polyolefin; This section YY/T Section 10698 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

Requirements and test methods other medical device packaging will be specified in the YY/T 0698 in other parts. Appendix A of this standard is a normative appendix.

Introduction

ISO 116071 series of standards under the general title "Packaging for terminally sterilized medical devices", consists of two parts. Part 1 of the series of standards Which provides, expected before use to keep terminally sterilized medical devices sterile preformed sterile barrier systems, sterile barrier systems and packaging systems General requirements and test methods. Part 2 of the series of standards specifies validation requirements forming, sealing and assembly processes.

Each sterile barrier system must meet the requirements of ISO 11607-1.

YY/T 0698 series of standards can be used to demonstrate compliance with one or more of the requirements specified in ISO 11607-1.

When a standard setting, ISO 11607 series of standards being converted to our standards. The future of the corresponding standard is GB/T 19633 series of standards.

1 Scope

YY/T 0698 provisions of this part of the terminally sterilized medical devices packaging plastic packaging co-extruded plastic film (hereinafter referred to as "plastic film")

Requirements and test methods.

This standard applies to the co-extruded plastic film instrumentarija medical equipment for plastic packaging.

This part is not general requirements for ISO 11607-1 requirements increase, so that in the 4.2 to 4.5 can be used to demonstrate compliance with special requirements One or more of the requirements of ISO 11607-1, but not all of its requirements.

The plastic film and other packaging materials medical equipment sterile barrier system, which enables the user before opening the package to see the contents, in order to In aseptic.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

Determination of GB/T 458-2008 air permeability of paper and cardboard Determination of GB/T 1040 (all parts) Tensile Properties of Plastics

GB/T 6672 plastic film and sheeting - Determination of thickness by mechanical scanning Determination of GB/T 6673 plastic film and sheet length and width

GB/T 7408 Data elements and interchange formats - Information interchange the date and time notation

GB/T 8809 plastic film anti-pendulum impact test GB/T Determination of plastic film and sheet tear resistance of 16578.1 - Part 1. Trouser tear method

3 Terms and Definitions

Terms and definitions defined in ISO 11607-1 apply to this document.

4 Requirements