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GB/T 42067-2022Water-soluble biodegradable medical textiles packaging bags made from film (English PDF)

水溶性生物降解医用织物包装膜袋

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

October 14, 2022

Implementation date

May 1, 2023

Scope

GB/T 42067-2022 is the English-translated version of 水溶性生物降解医用织物包装膜袋.

GB/T 42067-2022 is the Chinese national standard for the water-soluble, biodegradable film bags used to pack soiled and infectious reusable medical textiles.

It classifies them by the items packed and by water solubility temperature, then sets the requirements and the matching test method for each property: structure, appearance, thickness deviation, water solubility, tensile strength and elongation at break, impact resistance and heat seal strength, load-bearing and drop performance, airtightness, microbial barrier, acute toxicity and biodegradability.

Inspection rules cover the batch, the inspection classes, the sampling plan and the decision rules, and a final chapter deals with marking, packaging, transport and storage.

It does not apply to non-medical plastic film bags. Among the standards it quotes are GB/T 2828.1, GB/T 9639.1-2008, GB/T 41010 and WS/T 508-2016. Issued on 14 October 2022, it has applied since 1 May 2023.

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Document preview — GB/T 42067-2022

National Standard of the People's Republic of China

ICS
83.140.01
Classification
Y 28

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Preface
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Category
  • 4.1 Classification by Packaged Items
  • 4.2 Classification by water solubility temperature
  • 5 Requirements
  • 5.1 Structure
  • 5.2 Appearance
  • 5.3 Thickness deviation
  • 5.4 Water solubility
  • 5.5 Tensile strength and elongation at break, tensile force
  • 5.6 Impact resistance and heat seal strength
  • 5.7 Load-bearing performance
  • 5.8 Drop performance
  • 5.9 Airtightness
  • 5.10 Microbial barrier properties
  • 5.11 Acute toxicity
  • 5.12 Biodegradability
  • 6 Test method
  • 6.1 Structure
  • 6.2 Appearance
  • 6.3 Thickness deviation
  • 6.4 Water solubility
  • 6.5 Tensile strength and elongation at break, tensile force
  • 6.6 Impact resistance and heat seal strength
  • 6.7 Load-bearing performance
  • 6.8 Drop performance
  • 6.9 Airtightness
  • 6.10 Microbial barrier properties
  • 6.11 Acute toxicity
  • 6.12 Biodegradability
  • 7 Inspection rules
  • 7.1 Batch
  • 7.2 Inspection classification
  • 7.3 Sampling plan
  • 7.4 Decision Rules
  • 8 Marking, packaging, transportation, storage
  • 8.1 Signs
  • 8.2 Packaging
  • 8.3 Transport
  • 8.4 Storage

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

1 Scope

This document specifies the classification, requirements, inspection rules, packaging, marking, transportation and storage of water-soluble biodegradable medical fabric packaging film bags exists and describes a test method for water-soluble biodegradable medical fabric packaging film bags.

This document is applicable to the water-soluble packaging of reusable medical fabrics (including infectious fabrics, soiled fabrics) after special use film bag.

This document does not apply to plastic film bags for non-medical packaging.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 1040.3 Determination of Tensile Properties of Plastics Part 3: Test Conditions for Films and Sheets

GB/T 2828.1 Counting Sampling Inspection Procedure Part 1: Lot-by-Lot Inspection Sampling Plan Retrieved by Acceptance Quality Limit (AQL)

GB/T 6672 Plastic Film and Sheet Thickness Determination Mechanical Measurement Method

GB/T 9639.1-2008 Test method for impact resistance of plastic films and sheets - Free-fall dart method - Part 1: Cascade method

GB/T 21281 Hazardous chemicals fish acute toxicity classification test method

GB/T 21830 Chemical flea acute activity inhibition test

GB/T 22797-2009 Sheets

GB/T 41010 Biodegradable plastics and products degradation performance and labeling requirements

BB/T 0039-2013 Commodity retail packaging bags

HJ421-2008 Standard for packaging bags, containers and warning signs for medical waste

QB/T 2358 Test method for heat sealing strength of plastic film packaging bags

WS/T 508-2016 Technical specification for washing and disinfection of hospital medical fabrics Technical Specifications for Disinfection (2002 Edition) (Wei Fa Jian Fa [2002] No. 282)

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Water-solublematerials

Membrane material with rapid rupture and complete dissolution in water at a specific temperature.

3.2 Medical textiles

Reusable textiles in healthcare facilities.

Examples. Clothes, sheets, quilts, pillowcases used by patients; work clothes and caps used by staff; surgical gowns, surgical sheets; bed curtains, curtains, and environmental

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

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