標(biāo)準(zhǔn)編號:	YY/T 0698.7-2009
中文名稱:	最終滅菌醫(yī)療器械包裝材料 第7部分：環(huán)氧乙烷或輻射滅菌屏障系統(tǒng)生產(chǎn)用可密封涂膠紙 要求和試驗方法
英文名稱:	Packaging materials for terminal sterilized medical devices - Part 7: Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide
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):	國家食品藥品監(jiān)督管理局
發(fā)布日期:	2009-6-16
實施日期:	2010-12-1
標(biāo)準(zhǔn)狀態(tài):	valid
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	14000 字
翻譯價格(元):	840.0
交付時間:	付款后 1 個工作日

Packaging materials for terminal sterilized medical devices - Part 7：Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods 1 Scope This part of YY/T 0698 specifies the requirements and test methods for the manufacture of sealable adhesive coated paper meeting those specified in YY/T 0698.6. The packaging materials are used as the packaging of medical devices terminally subjected to sterilization by ethylene oxide or irradiation. No requirements are added to the general requirements of ISO 11607-1 in this part, only guidelines are provided for elements on the basis of ISO 11607-1 and relevant national standards. Therefore, the specific requirements in 4.2~4.3 may be used to confirm one or more requirements of ISO 11607-1, but not all requirements. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY/T 0698. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this part of YY/T 0698. However parties to agreements based on this part of YY/T 0698 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. GB/T 451.2 Paper and board - Determination of grammage (GB/T 451.2-2002; eqv ISO 536: 1995) GB/T 454 Paper - Determination of bursting strength (GB/T 454-2002; idt ISO 2758: 2001) GB/T 455 Paper and board - Determination of tearing resistance (GB/T 455-2002; eqv ISO 1974: 1990) GB/T 458 Paper and board - Determination of air permeance (GB/T 458-2008; ISO 5636-2: 1984; ISO 5636-3: 1992; ISO 5636-5: 2003, MOD) GB/T 465.1 Paper and board - Determination of bursting strength after immersion in water (GB/T 465.1-2008; ISO 3689: 1983, IDT) GB/T 465.2 Paper and board - Determination of tensile strength after immersion in water (GB/T 465.2-2008; ISO 3781: 1983, IDT) GB/T 1540 Paper and board - Determination of water absorption - Cobb method (GB/T 1540-2002; neq ISO 535: 1991) GB/T 1545.2 Paper, board and pulp - Determination of pH of aqueous extracts (GB/T 1545.2-2003; mod ISO 6588: 1981) GB/T 2678.6 Paper, board and pulp - Determination of water soluble sulphates (Conductimetric titration method) (GB/T 2678.6-1996; eqv ISO 9198: 1989) GB/T 7408 Data elements and interchange formats - Information interchange - Representation of dates and times (GB/T 7408 2005; ISO 8601: 2000, IDT) GB/T 7974-2002 Paper, board and pulp - Measurement of brightness - Diff/Geometry (neq ISO 2470: 1999) GB/T 12914 Paper and board - Determination of tensile properties (GB/T 12914-2008; ISO 1924-2: 1994, MOD) ISO 6588-2: 2005 Paper, board and pulps - Determination of pH of aqueous extracts - Part 2: Hot extraction ISO 9197 Paper, board and pulps - Determination of water-soluble chlorides ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems 3 Terms and definitions For the purpose of this part of YY/T 0698, the terms and definitions given in ISO 11607-1 apply. 4 Requirements 4.1 General The requirements of ISO 11607-1 apply. Note: The following specific requirements and test methods may be used to confirm one or more requirements of ISO 11607-1, but not all requirements.

Foreword i Introduction iii 1 Scope 2 Normative references 3 Terms and definitions 5 Information to be supplied by the manufacturer Annex A (Normative) Method for the determination of water repellency Annex B (Normative) Method for the determination of pore size Annex C (Normative) Method for determination of regularity of seal adhesive coatings on paper Annex D (Normative) Method for the determination of mass per unit area of uncoated paper and adhesive coating Annex E (Normative) Method for the determination of seal strength of the adhesive coating Bibliography