YY/T 0698.2-2022 English PDF (YYT0698.2-2022)

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YY/T 0698.2-2022: Packaging materials for final sterilized medical devices - Part 2: Requirements and test methods for sterilized packaging materials
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...