มาตรฐาน/กฎระเบียบ

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มาตรฐาน/กฎระเบียบ
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มาตรฐานเกี่ยวกับเจลแอลกอฮอล์ / น้ำยาฆ่าเชื้อ

  Title Standard No. หมายเหตุ
1 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations ASTM E1174-13  
2 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults ASTM E2755-15  
3 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations ASTM E3058-16  
4 Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces AAMI TIR 68:2018  
มาตรฐาน/กฎระเบียบ
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มาตรฐานเกี่ยวกับ Negative Pressure Facility / AIIR

  Title Standard No. หมายเหตุ
1 Ventilation of Health Care Facilities ANSI/ASHRAE/ASHE Standard 170-2017  
2 Guidelines for Environmental Infection Control in Health-Care Facilities CDC  
3 Thermal performance of buildings – Determination of air permeability of buildings – Fan pressurization method (ISO 9972:1996, modified) EN 13829  
4 Thermal insulation in buildings – Determination of air change in buildings – Tracer gas dilution method EN ISO 12569  
5 Ergonomics of the thermal environment – Analytical  determination and interpretation of thermal comfort using calculation of the PMV and PPD indices and local thermal comfort criteria EN ISO 7730  
6 Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1. ISO 14644-2  
7 Cleanrooms and associated controlled environments: Part 3 - Metrology and test methods ISO 14644-3  
8 Thermal environments, Instruments and methods for measuring physical quantities ISO 7726  
มาตรฐาน/กฎระเบียบ
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มาตรฐานเกี่ยวกับเครื่องช่วยหายใจ

  Title Standard No. หมายเหตุ
1 Standard Practice for Respiratory Protection ASTM F3387-19  
2 Medical Devices - Anesthesiology Devices  21 CFR 868  
3 Medical device software - Software life-cycle processes BS EN 62304:2006+A1:2015  
4 Particular requirements for emergency and transport ventilators BS EN 794-3:1998+A2:2009  
5 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) ISO 14971:2012  
6 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests BS EN ISO 60601-1-2:2015  
7 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators BS EN ISO 60601-2-12:2020  
8 Lung ventilators and related equipment. Vocabulary and semantics BS ISO 19223:2019  
9 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Corrigendum 1 - Amendment 1 IEC 60601-1:2005/AMD1:2012/COR1:2014  
10 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601-1-2:2014  
11 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-6:2010  
12 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-8:2006  
13 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment IEC 62353:2014  
14 Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015  
15 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices IEC/TR 62366-2:2016  
16 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices ISO 10524-1:2018  
17 Lung ventilators for medical use - Part 1: Requirements ISO 10651-1:1993  
18 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients ISO 10651-2:2004  
19 Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators ISO 10651-3:1997  
20 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14937:2009  
21 Medical devices — Application of risk management to medical devices ISO 14971:2019  
22 Lung ventilators and related equipment — Vocabulary and semantics ISO 19223:2019  
23 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance ISO 23328-1:2003  
24 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects ISO 23328-2:2002  
25 Medical electrical equipment – Part 1: General requirements for safety ISO 601-1:1975  
26 Medical electrical equipment – Part 1: General requirements for safety – Electromagnetic compatibility – Requirements and tests  ISO 601-1-2:1993  
27 Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators ISO 80601-2-12:2020  
28 Medical electrical equipment — Part 2-84: Particular requirements for basic safety and essential performance of ventilators for the emergency medical services environment ISO 80601-2-84:2018  
29 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
ISO 8185:2007 wd		  
มาตรฐาน/กฎระเบียบ
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มาตรฐานเกี่ยวกับถุงมือทางการแพทย์

  Title Standard No. หมายเหตุ
1 Standard Specification for Rubber Examination Gloves ASTM D3578-19  
2 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application ASTM D5250-19  
3 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-19  
4 Standard Specification for Polychloroprene Examination Gloves for Medical Application ASTM D6977-19  
5 Protective gloves - General requirements and test methods DIN EN 420:2010-03  
6 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes DIN EN 455-1:2001-01  
7 Medical gloves for single use – Part 2: Requirements and testing for physical properties DIN EN 455-2:2015-07  
8 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation DIN EN 455-3:2015-07  
9 Medical gloves for single use – Part 4: Requirements and testing for shelf life determination DIN EN 455-4:2009-10  
10 Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks DIN EN ISO 374-1:2018-10  
11 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016) DIN EN ISO 374-5:2017-03  

 

มาตรฐาน/กฎระเบียบ
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มาตรฐานเกี่ยวกับหน้ากากอนามัย หน้ากากผ้า N95

 
  Title Standard No. หมายเหตุ
1 Approval of Respiratory Protective Devices 42 CFR 84  
2 Respiratory protective devices AS/NZS 1716-2012  
3 Standard Specification for Performance of Materials Used in Medical Face Masks ASTM F2100-19  
4 Medical face masks. Requirements and test methods BS EN 14683:2019  
5 Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking BS EN 149:2001+A1:2009  
6 มาตรฐานหน้ากาก N95 ทางการแพทย์ของจีน GB 19083  

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