標(biāo)準(zhǔn)編號(hào):	YY/T 0698.2-2022
中文名稱:	最終滅菌醫(yī)療器械包裝材料 第2部分：滅菌包裹材料 要求和試驗(yàn)方法
英文名稱:	Packaging materials for final sterilized medical devices-Part 2: Requirements and test methods for sterilized packaging materials
中標(biāo)分類:	C31    一般與顯微外科器械
行業(yè)分類:	YY    醫(yī)藥行業(yè)標(biāo)準(zhǔn)
發(fā)布機(jī)構(gòu):	國(guó)家藥品監(jiān)督管理局
發(fā)布日期:	2022-10-17
實(shí)施日期:	2023-10-1
標(biāo)準(zhǔn)狀態(tài):	valid
替代舊標(biāo)準(zhǔn):	YY/T 0698.2-2009 最終滅菌醫(yī)療器械包裝材料 第2部分：滅菌包裹材料 要求和試驗(yàn)方法
翻譯語(yǔ)言:	英文
文件格式:	PDF
中文字符數(shù):	15000 字
翻譯價(jià)格(元):	1050.0
交付時(shí)間:	付款后 1 個(gè)工作日

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