YY/T 0698.2-2022 English PDF (YY/T 0698.2-2009)

YY/T 0698.2-2022_English: PDF (YY/T0698.2-2022)
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 0698.2-2022230 Add to Cart Auto, < 3 mins Packaging materials for final sterilized medical devices - Part 2: Requirements and test methods for sterilized packaging materials Valid
YY/T 0698.2-2009145 Add to Cart Auto, < 3 mins Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. Requirements and test methods Obsolete

BASIC DATA
Standard ID YY/T 0698.2-2022 (YY/T0698.2-2022)
Description (Translated English) (Packaging materials for terminally sterilized medical devices - Part 2: Requirements and test methods for packaging materials for sterilization)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Word Count Estimation 15,150
Date of Issue 2022-10-17
Date of Implementation 2023-10-01
Older Standard (superseded by this standard) YY/T 0698.2-2009
Administrative Organization State Food and Drug Administration
Summary This International Standard specifies requirements and test methods for materials of preformed barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until use. This standard applies to the determination of the properties of plain paper wrapping materials, crepe paper wrapping materials, non-woven fabric wrapping materials and textile wrapping materials intended for repeated use intended for single use.

BASIC DATA
Standard ID YY/T 0698.2-2009 (YY/T0698.2-2009)
Description (Translated English) Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. Requirements and test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.080.040
Word Count Estimation 15,184
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Quoted Standard GB/T 451.2; GB/T 454; GB/T 455; GB/T 458; GB/T 465.1; GB/T 465.2; GB/T 1540; GB/T 1545.2; GB/T 2678.6; GB/T 3917.1-1997; GB/T 4744; GB/T 4745-1997; GB/T 5453-1997; GB/T 7408; GB/T 7742.1; GB/T 7974-2002; GB/T 12914; ISO 6588-2-2005; ISO 9073-3; ISO 9073-9; ISO 9197; ISO 11607-1; EN 1149-1-2006
Drafting Organization Shandong Province Quality Inspection Center of Medical Devices
Administrative Organization Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Proposing organization National Standardization Technical Committee appliances Infusion
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the expected before use to keep terminally sterilized medical devices preformed sterile barrier systems and packaging systems for material requirements and test methods. This part is not general requirements for ISO 11607-1 requirements increase, so that 4. 2 requirements for ISO 11607-1 can be used to demonstrate compliance with one or more of the requirements, but not all of its requirements.


YY/T 0698.2-2022 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080.040 CCS C 31 Replace YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods 最终灭菌医疗器械包装材料 ISSUED ON: OCTOBER 17, 2022 IMPLEMENTED ON: OCTOBER 1, 2023 Issued by: National Medical Products Administration Table of Contents Foreword ... 3 Introduction ... 6 1 Scope ... 7 2 Normative references ... 7 3 Terms and definitions ... 8 4 Requirements ... 8 5 Information provided by the manufacturer ... 13 Appendix A (Normative) Test method for determining hydrophobicity ... 14 Appendix B (Informative) Test method for determining drapability ... 16 Appendix C (Normative) Test method for determining aperture ... 18 References ... 24 Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods 1 Scope This document specifies requirements and test methods for materials of preformed barrier systems and packaging systems that are intended to maintain the sterility of terminally sterilized medical devices until use. This document is applicable to the determination of the properties of flat paper wrapping materials, crepe paper wrapping materials, and nonwoven wrapping materials intended for single use, as well as textile wrapping materials intended for repeated use. 2 Normative references The following documents contain the provisions which, through normative reference in this document, constitute the essential provisions of this document. For the dated referenced documents, only the versions with the indicated dates are applicable to this document; for the undated referenced documents, only the latest version (including all the amendments) is applicable to this document. 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/T3917.1 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 inter change 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 (20 mm/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, 2020 Edition, Vol. 4 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 The terms and definitions defined in GB/T 19633.1 apply to this document. 4 Requirements 4.1 General rule For the materials for preformed sterile barrier systems and sterile barrier systems, the requirements of GB/T 19633.1 are applicable. Only the operational performances and test methods of the materials included are provided in this document, the general requirements specified in GB/T 19633.1 are not as required. Note: See Appendix B, GB/T 23329, ISO 9073-9, and GB/T 8942 for the test method. 4.2.2 Specific requirements 4.2.2.1 Flat paper wrapping materials 4.2.2.1.1 When tested according to GB/T 455, the tearing strength of the wrapping material along the machine direction and in the transverse direction shall not be less than 500 mN. See GB/T 450 for the determination of machine direction and transverse direction. 4.2.2.1.2 When tested according to the Bendtsen method specified in GB/T 458, under the air pressure of 1.47 kPa, the air permeability of the wrapping material shall not be less than 1.7 μm/(Pa • s). 4.2.2.1.3 When tested according to GB/T 454, the bursting strength of the wrapping material shall not be less than 110 kPa. 4.2.2.1.4 When tested with an immersion of 10 min according to GB/T 465.1, the wet bursting strength of the wrapping material shall not be less than 35 kPa. 4.2.2.1.5 When tested according to Appendix A, the hydrophobicity of the wrapping material shall be such that the penetration time is not less than 20 s. 4.2.2.1.6 When tested according to Appendix C, the average pore diameter of 10 samples shall not exceed 35 μm, and the maximum value shall not exceed 50 μm. 4.2.2.1.7 When tested according to GB/T 12914, the tensile strength of the wrapping material shall not be less than 1.33 kN/m along the machine direction, and not less than 0.67 kN/m in the transverse direction. 4.2.2.1.8 When tested according to GB/T 465.2, the wet tensile strength of the wrapping material shall not be less than 0.33 kN/m along the machine direction, and not less than 0.27 kN/m in the transverse direction. 4.2.2.1.9 When tested with a test time of 60 s (Cobb method) according to GB/T 1540, the water absorption (Cobb value) of each side of the paper shall not exceed 20 g/m2. 4.2.2.2 Crepe paper wrapping material 4.2.2.2.1 The wrapping material of crepe paper shall be wrinkled to improve its softness. 4.2.2.2.2 When tested according to GB/T 12914, the elongation at break of the wrapping material shall not be less than 10% along the machine direction and not less than 2% in the transverse direction. 4.2.2.2.3 When tested according to Appendix A, the hydrophobicity of the wrapping material shall be such that the penetration time is not less than 20 s. 4.2.2.2.4 When tested according to Appendix C, the average pore diameter of 10 samples shall not exceed 35 μm, and the maximum value shall not exceed 50 μm. 4.2.2.2.5 When tested according to GB/T 12914, the tensile strength of the wrapping material shall not be less than 1.33 kN/m along the machine direction, and not less than 0.67 kN/m in the transverse direction. 4.2.2.2.6 When tested according to GB/T 465.2, the wet tensile strength of the wrapping material shall not be less than 0.33 kN/m along the machine direction, and not less than 0.27 kN/m in the transverse direction. 4.2.2.3 Nonwoven wrapping materials Note: The nonwovens used for sterile barrier systems mentioned in this section can be understood they are made of textile fibers and/or nonwoven fibers. 4.2.2.3.1 When tested according to GB/T 455, the intrinsic tearing strength of the nonwoven wrapping material shall not be less than 750 mN along the machine direction, and not less than 1000 mN in the transverse direction. 4.2.2.3.2 When tested according to GB/T 454, the bursting strength of the wrapping material shall not be less than 130 kPa. 4.2.2.3.3 When tested with a water immersion of 10 min according to GB/T 465.1, the wet bursting strength of the nonwoven shall not be less than 90 kPa. 4.2.2.3.4 When tested according to GB/T 12914, the elongation at break of the nonwoven shall not be less than 5% along the machine direction and not less than 7% in the transverse direction. 4.2.2.3.5 When tested according to GB/T 12914, the tensile strength of the nonwoven wrapping material shall not be less than 1.00 kN/m along the machine direction, and not less than 0.65 kN/m in the transverse direction. 4.2.2.3.6 When tested according to GB/T 465.2, the wet tensile strength of the nonwoven wrapping material shall not be less than 0.75 kN/m along the machine direction, and not less than 0.50 kN/m in the transverse direction. 4.2.2.3.7 The test results of the waterproof performance of nonwoven wrapping materials shall be determined and recorded according to the hydrostatic pressure method in GB/T 4744. 4.2.2.4 Textile wrapping materials Appendix A (Normative) Test method for determining hydrophobicity A.1 Instrument A.1.1 Ultraviolet light source (UV-A, 315 nm~390 nm) and ultraviolet radiation meter. A.1.2 Flat plate, about 200 mm×150 mm×15 mm. A.1.3 Dryer. A.1.4 Stopwatch. A.1.5 A powder-dusting instrument that has a sieve with a nominal aperture of 0.125 mm~0.150 mm at one end and a closed end at the other end. A.2 Reagents The dry indicator powder shall be prepared as follows: Crush 20 g of sucrose and sift it through a sieve with a nominal aperture of 0.063 mm~0.075 mm. Place the sifted sucrose above the silica gel in a desiccator or dry it in an oven at 105 °C to 110 °C. Mix 10 g of dried sucrose with 10 mg of sodium fluorescein, and sift the mixed powder through a sieve with a nominal aperture of 0.063 mm~0.075 mm 5 times. Finally, transfer the dry indicator powder to the powder-dusting instrument. The dry indicator powder in the powder-dusting instrument shall be stored in a desiccator or in an oven at 105 °C to 110 °C. A.3 Steps Take 10 conditioned paper specimens, each 60 mm×60 mm, and divide them into two groups, 5 specimens for each group. For one group, let the “wrapping side”......


YY/T 0698.2-2009 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080.040 C 31 Packaging materials for terminal sterilized medical devices - Part 2. Sterilization wrap – Requirements and test methods 最终灭菌医疗器械包装材料 ISSUED ON. JUNE 16, 2009 IMPLEMENTED ON. DECEMBER 1, 2010 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  Introduction ... 5  1 Scope ... 6  2 Normative references ... 6  3 Terms and definitions ... 8  4 Requirements ... 8  5 Information to be supplied by the manufacturer ... 12  Annex A ... 14  Annex B ... 16  Annex C ... 21  Annex D ... 23  Bibliography ... 25  Foreword YY/T 0698 Packaging materials for terminal sterilized medical devices consists of the following parts. - Part 2. Sterilization wrap - Requirements and test methods - Part 3. Paper for use in the manufacture of paper bags (specified in YY/T 0698.4) and in the manufacture of pouches and reels (specified in YY/T 0698.5) - Requirements and test methods - Part 4. Paper bags - Requirements and test methods - Part 5. Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods - Part 6. Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization pro - Part 7. Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide - Part 8. Re-usable sterilization containers for steam sterilizers - Requirements and test methods - Part 9. Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids - R - Part 10. Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids - Requirements and test methods This Part is the second part of YY/T 0698. Other requirements and test methods for other packaging materials for terminal sterilized medical devices shall be stipulated in other parts. This Part of YY/T 0698 refers to and adopts prEN 868-2.2007 Packaging materials for terminal sterilized medical devices - Part 2. Sterilization wrap - Requirements and test methods. Annex A, Annex B, Annex C and Annex D of this Part are normative. This Part was proposed by National Technical Committee on Infusion Equipment for Medical of Standardization Administration of China. This Part shall be under the jurisdiction of China Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. Packaging materials for terminal sterilized medical devices - Part 2. Sterilization wrap – Requirements and test methods 1 Scope This Part of YY/T 0698 provides test methods and values for materials for preformed sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. This Part introduces no additional requirements to the general requirements specified in ISO 11607-1. As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of ISO 11607-1. NOTE 1. If the intended use as specified by the manufacturer includes the possibility of the material being used as a sterile field or a surgical drape the YY/T 0506 series applies. NOTE 2. If the intended use as specified by the manufacturer includes the possibility of the material being used as container filter or as an inner wrap for containers then additional and/or other requirements can apply, see e. g. YY/T 0698.8. 2 Normative references The following standards contain the provisions which, through reference in this Part of YY/T 0698, constitute the provisions of this Part. For dated references, subsequent amendments (excluding corrections) or revisions do not apply to this Part. However, the parties who enter into agreement based on this Part are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest versions apply to this Part. 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 3689.1983, 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 3917.1-1997 Textiles - Tear properties of fabrics - Part 1. Determination of tear force - Ballistic pendulum method (Elmendorf) (GB/T 3917.1-1997, neq ISO/DIS 13937-1.1995) GB/T 4744 Textiles - Testing and evaluation for water resistance - Hydrostatic pressure method (GB/T 4744-1997, eqv ISO 811.1981) GB/T 4745-1997 Textile fabrics - Determination of resistance to surface wetting - Spray test (GB/T 4745-1997, eqv ISO 4920.1981) GB/T 5453-1997 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 7408-2005, ISO 8601.2000, IDT) GB/T 7742.1 Textiles - Bursting properties of fabrics - Part 1. Hydraulic method for determination of bursting strength and bursting distension (GB/T 7742.1-2005, ISO 13938-1.1999, MOD) 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 9073-3 Textiles - Test methods for nonwovens - Part 3. Determination of Bibliography GB/T 10739 Paper, board and pulps standard atmosphere for conditioning and testing GB/T 19633 Packaging for terminally sterilized medical devices YY/T 0506.1 Surgical drapes gowns and clean air suits for patients clinical staff and equipment - Part 1. General requirements for manufacturers processors and products EN 13795-36 Surgical Drapes, Gowns And Clean Air Suits, Used As Medical Devices For Patients, Clinical Staff And Equipment - Part 3. Performance Requirements and Performance Levels 6 YY/T 0506-2, the industrial standard corresponding to EN 13795-3 is under stipulation. ......


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