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  1. HOME
  2. Standards for Class II non-sterile products

Class II non-sterile products

Class II non-sterile products, Total:122 items.

The international standard classification for "Class II non-sterile products" includes: food products in general , Other standards related to sterilization and disinfection , Farming and forestry in general , Farming and forestry , Sterilization and disinfection in general .

The Chinese standard classification for "Class II non-sterile products" includes: Technical management , Basic standards and general methods , Other cash crops , Technical management , Public medical equipment .

Professional Standard - Agriculture

Group Standards of the People's Republic of China

  • T/QGCML 4381-2024 Mechanical sealing equipment for sterile products
  • T/ZGKSL 002-2020 General requirements for non-heat-sterilized prickly pear pure juice products
  • T/CQAP 3001-2020 Requirements of parametric release for sterile products using terminal moist heat sterilization
  • T/CPAPE 01-2022 The Manufacture of Sterile Products Using Blow-Fill-Seal Technology
  • T/CIET 357-2024 Technical specifications for production operations of blow-fill-seal (BFS) sterile products
  • T/CPAPE 01-2024 Technical Guide for contamination control strategies in aseptic drug production
  • T/NTTIC 015-2018 Far infrared antibacterial pillow, cushion products
  • T/GDES 20002-2016 Carbon footprint of product —— Category rules of a product Pasteurized milk

Guangdong Provincial Standard of the People's Republic of China

  • DB44/T 1874-2016 Product Carbon Footprint Product Category Rules Pasteurized Milk

Professional Standard - Light Industry

  • QB/T 5881-2023 Test method for sterilization ofincense burning products

国家林业和草原局

  • LY/T 3264-2021 Quality grade of major forest by-products — Edible fungus

国家市场监督管理总局、中国国家标准化管理委员会

  • GB/T 37109-2018 Basic information description of agricultural products—Eedible mushrooms

国家药监局

  • YY/T 0567.2-2021 Aseptic processing of health care products-Part 2:Sterilizing filtration

Professional Standard - Medicine

Shanxi Provincial Standard of the People's Republic of China

  • DB14/T 629-2011 Technical regulations for the production of Hericium erinaceus in pollution-free food

Tianjin Provincial Standard of the People's Republic of China

  • DB12/ 209-2004 Safety and quality requirements for edible fungi of pollution-free agricultural products
  • DB12/T 212-2005 Technical specification for controlled cultivation of edible fungi for pollution-free agricultural products

国家食品药品监督管理局

  • YY/T 0507.2-2005 Sterile processing of medical products Part 2: Filtration
  • YY/T 0507.1-2005 Sterile processing of medical products Part 1: General requirements

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

Xinjiang Provincial Standard of the People's Republic of China

  • DB65/T 2934-2009 Pollution.free agriculture products Rules of strains cultural of Pleurotus ferulas Lanzi

未注明发布机构

  • CAN/CSA-ISO/TS 17665-3:2017 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Jilin Provincial Standard of the People's Republic of China

  • DB22/T 1189.3-2011 Pollution-free agricultural products Gastrodia elata part 3 technical regulations for fungal material production

2001/05/01

  • DB1304/T 085-2001 Technical Regulations for the Production of Pollution-free Agricultural Products Edible Fungi

Defense Logistics Agency

SCC

  • AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
  • CAN/CGSB 20.27-M91-1991 Sterile or non-sterile, single-use medical examination gloves
  • CAN/CGSB-20.27-M91-1991 Sterile or Non-Sterile Medical Examination Gloves for Single Use
  • ADA 76-2005(R2015) Non-Sterile Rubber Latex Gloves
  • CAN/CGSB 3.0 No.105.3-1995 Method of Testing for Petroleum and Related Products - Sulfates in Uninhibited Ethylene Glycol
  • ADA 102-1999(R2015) Non-Sterile Nitrile Gloves for Dentistry
  • DANSK DS/ISO/TS 22456:2021 Sterilization of healthcare products – Microbiological methods – Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
  • DANSK DS/EN 14333-1:2004 Non fatty foods - Determination of benzimidazole fungicides carbendazim, thiabendazole and benomyl (as carbendazim) - Part 1: HPLC method with solid phase extraction clean-up
  • UNE-EN 14333-3:2005 Non fatty foods - Determination of benzimidazole fungicides carbendazim, thiabendazole and benomyl (as carbendazim) - Part 3: HPLC method with liquid/liquid-partition clean up
  • ADA 103-1999(R2015) Non-Sterile Poly Vinyl Chloride Gloves for Dentistry
  • BS CWA 14698-1:2003 Principles to create a standardized framework for the classsification of non-food products

RO-ASRO

  • STAS 2356-1982 MEAT AND MEAT PRODUCTS Bacteriological analysis
  • SR 2356-2-1994 Meat and meat products Bacteriological conditions
  • STAS 4605/7-1972 NON-METAL BEAR IN G MINING PRODUCTS WITH CARBONATE CONTENT Determinalion of titanium dioxide
  • STAS 12922/2-1991 Fish and fish products. Coliforms number determination
  • STAS 12922/3-1991 Fish and fish products Presumptive number determination of Escherichia coli bacteria
  • STAS 2213/10-1987 SWEET PHODUCTS Determination of total anii free sul- phur dioxide
  • STAS 4605/5-1972 NON-METAL BEARING MINING PRODUCTS WITH CARBONATE CONTENT Determination of iron triox'de

American National Standards Institute （ANSI)

  • ANSI/AAMI/ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
  • ANSI/AAMI ST67-2011 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile
  • ANSI/AAMI/ISO 13408-2:2003 Aseptic Processing of health care products - Part 2: Filtration
  • ANSI/AAMI/ISO 13408-5:2006 Aseptic Processing of health care products - Part 5: Sterilization in place

Association of Official Analytical Chemists (AOAC)

RU-GOST R

  • GOST R 51278-1999 Cereals, pulses and derived products. Enumeration of bacteria, yeasts and moulds
  • GOST R 50380-2005 Fish, non-fish objects and products from them. Terms and definitions
  • GOST R 53184-2008 Fish, marine invertebrates and products of their processing. Determination of dioxins and dioxin-like biphenyls by GC-MS method
  • GOST 15.009-1991 System of product development and launching into manufacture. Non-food consumer goods
  • GOST R 52409-2005 Products of non-alcoholic and low-alcoholic industry. Terms and definitions
  • GOST R ISO 13408-2-2007 Aseptic processing of health care products. Part 2. Filtration

International Organization for Standardization (ISO)

  • ISO 13408-2:2018 Aseptic processing of health care products — Part 2: Sterilizing filtration
  • ISO 13408-6:2006/Amd 1:2013 Aseptic processing of health care products - Part 6: Isolator systems; Amendment 1
  • ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
  • ISO/TS 15843:2000 Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
  • ISO 13408-5:2006 Aseptic processing of health care products - Part 5: Sterilization in place

US-FCR

IL-SII

  • S.I.641-1967 TESTING OF MILK AND ITS PRODUCTS: TEST OF STERILITY OF LIQUID PRODUCTS

PL-PKN

US-AAMI

  • ANSI/AAMI/ISO TIR17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization

Association Francaise de Normalisation

VN-TCVN

PT-IPQ

  • NP 2078-1985 Edible microorganisms. Cereals, legumes and similar products. Yeast and mold calculations

GSO

  • BH GSO CODEX STAN 38:2015 Edible fungi and fungus products
  • BH GSO ISO/TS 22456:2023 Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
  • GSO ISO/TS 22456:2023 Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

UNKNOWN

  • GB/T 18282.5-2015 Chemical Indicators for Sterilization of Healthcare Products Part 5: Class II Indicators for Class BD Air Exclusion Tests

TR-TSE

  • TS 3446-1979 MEAT AND MEAT PRODUCTS DETECTION OF SALMONELLAE (REFERENCE METHOD)

CZ-CSN

  • CSN 46 3195-1997 Edible fungi and fungus products
  • CSN ISO 6391:1995 Meat and meat products-Enumeration of Escherichia coli-Colony count technique at 44℃ using membranes

British Standards Institution (BSI)

  • BS ISO 13408-7:2012 Aseptic processing of health care products. Alternative processes for medical devices and combination products
  • BS EN ISO 13408-2:2018 Aseptic processing of health care products. Sterilizing filtration

KR-KS

Korean Agency for Technology and Standards (KATS)

CEN - European Committee for Standardization

  • EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration

European Committee for Standardization (CEN)

  • EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

Class II non-sterile products,Non-sterile product medical devices,non-sterile product

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