YY/T 0698.2-2022 Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
1 Scope
This document specifies the requirements and test methods for materials of preformed barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
This document is applicable to the performance determination of plain paper wraps, creped paper wraps and nonwoven wraps intended to be disposable, as well as textile wraps intended to be reusable.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 451.2 Paper and board - Determination of grammage
GB/T 454 Paper - Determination of bursting strength
GB/T 455 Paper and board determination of tearing resistance
GB/T 458 Paper and board - Determination of air permeance
GB/T 465.1 Paper and board - Determination of bursting strength after immersion in water
GB/T 465.2 Paper and board - Determination of tensile strength after immersion in water
GB/T 1540 Paper and board - Determination of water absorption - Cobb method
GB/T 1545 Paper, board and pulp - Determination of acidity or alkalinity
GB/T 3917.1 Textiles - Tear properties of fabrics - Part 1: Determination of tear force using ballistic pendulum method (Elmendorf)
GB/T 4744 Textiles - Testing and evaluation for water resistance - Hydrostatic pressure method
GB/T 5453 Textiles - Determination of the permeability of fabrics to air
GB/T 7408 Data elements and interchange formats - Information interchange - Representation of dates and times
GB/T 7742.1 Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension
GB/T 7974 Paper, board and pulps - Measurement of diffuse blue reflectance factor - D65 brightness (Diff/Geometry, Outdoor daylight conditions)
GB/T 10739 Paper, board and pulps - Standard atmosphere for conditioning and testing
GB/T 12914 Paper and board - Determination of tensile properties - Constant rate of elongation method (20mm/min)
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/T 24218.3 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation (strip method)
Pharmacopoeia of the People's Republic of China (Edition 2020) Volume IV
ISO 9197 Paper, board and pulps - Determination of water-soluble chlorides
ISO 9198 Paper, board and pulp - Determination of water-soluble sulfates
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 19633.1 apply.
4 Requirements
4.1 General
Foreword I
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information provided by the manufacturer
Annex A (Normative) Method for the determination of water repellency
Annex B (Informative) Test method for determination of drapability
Annex C (Normative) Method for determination of pore size
Bibliography
