#truststandards Стандартчиллын байгууллагууд цар тахлын эсрэг нэгдэж байна

Дэлхий нийтийг хамарсан COVID-19 тахлын үед  олон улсын стандартын байгууллагууд  цар тахлын үед ажиллах менежментийн тогтолцоо, техник хэрэгсэл, нэг удаагийн хувцас, ариутгалын бодисын стандартын мэдээллийг нээлттэй мэдээлж байна.

СТАНДАРТ, ХЭМЖИЛ ЗҮЙН ГАЗАР (MASM)

Эмнэлэгийн зориулалттай хамгаалах хувцас, гар ариутгалын шингэний дор дурдсан стандартуудыг өнөөдөр Монгол улсад хүчин төгөлдөр мөрдөж байна. Үүнд:

  • MNS 6623-1:2016 Эрүүл мэндийн зориулалттай нэг удаагийн хэрэгсэл. 1-р хэсэг. Малгай. Техникийн шаардлага,
  • MNS 6623-2:2016 Эрүүл мэндийн зориулалттай нэг удаагийн хэрэгсэл. 2-р хэсэг. Амны хаалт. Техникийн шаардлага,
  • MNS 6623-3:2016 Эрүүл мэндийн зориулалттай нэг удаагийн хэрэгсэл. 3-р хэсэг. Халаад. Техникийн шаардлага, Мэс заслын ариун халаад,
  • MNS 6623-4:2016 Эрүүл мэндийн зориулалттай нэг удаагийн хэрэгсэл. 4-р хэсэг. Гутлын өмсгөл. Техникийн шаардлага.
  • MNS 6159 : 2010 Этилийн спиртийн гар халдваргүйжүүлэгч гель. Ерөнхий шаардлага
  • MNS 6407 : 2013 Халдваргүйжүүлэлтийн явуулын байранд тавих техникийн ерөнхий шаардлага
  • MNS 6408 : 2013 Халдваргүйжүүлэлтийн суурин байранд тавих техникийн ерөнхий шаардлага
  • Стандарт, хэмжил зүйн газрын дэргэдэх Текстилийн стандартчиллын техникийн хороо холбогдох мэргэжлийн байгууллагуудаас санал авч боловсруулан, “MNS 6828:2020 Амны даавуун хаалт. Техникийн шаардлага” стандартыг батласан. Энэхүү стандартыг агаарын бохирдол, амьсгалын замын халдварт өвчнөөс урьдчилан сэргийлэх, тархалтыг бууруулах зориулалт бүхий олон удаа хэрэглэх амны даавуун хаалтны чанарын үзүүлэлт, шаардлагыг тогтоосон.

Эдгээр стандартуудыг www.estandard.gov.mn вэб хуудсаас уншиж, ашиглах боломжтой.

Монгол Засгийн газрын тохируулагч агентлаг Стандарт, хэмжил зүйн газрын гадаад хамтын ажиллагаатай олон улс, бүс нутаг, гадаад орны стандартчиллын байгууллагуудаас цар тахлын үед ажиллах удирлагын тогтолцооноос, техник хэрэгсэл, нэг удаагийн хувцасны стандартуудын жагсаалтаа ирүүлж, үнэ төлбөргүй унших, ашиглах боломж бүрдүүлсэн тухайгаа мэдээлээд байна. 

1.Олон улсын стандартчиллын байгууллага (ISO)

(хамгаалах хэрэгсэл, сэхээн амьдруулах, уушигны амьсгалын тоног төхөөрөмж, эрсдэл, ослын үеийн менежментийн тогтолцооны 20 гаруй стандартыг https://www.iso.org/covid19 хаягаас уншиж танилцах боломжтой)

  • ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risk
  • ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
  • ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
  • ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
  • ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
  • ISO 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes
  • ISO 13688:2013, Protective clothing – General requirements
  • ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
  • ISO 18082:2014, Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/AMD 1:2017, AMENDMENT 1]
  • ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
  • ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
  • ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
  • ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
  • ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
  • ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
  • ISO 22301:2019, Security and resilience – Business continuity management systems –Requirements
  • ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
  • ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management
  • ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes
  • ISO 31000:2018, Risk management – Guidelines
  • ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
  • ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
  • ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]
  • ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
  • ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
  • ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
  • ISO 80601-2-80:2018, Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

       • ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors

2. Олон улсын цахилгаан техникийн комисс (IEC)

(амьсгалын тоног төхөөрөмжийн 5 стандартыг https://webstore.iec.ch/webstore хаягаас дугаараар эсхүл “Access to key standards for critical care ventilators” гэж хайлт хийж үзэх, холбоо барьж үнэ төлбөргүй хүлээн авах боломжтой)

  • IEC 60601-1:2005+AMD1:2012 CSV, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
  • IEC 60601-1-6:2010+AMD1:2013 CSV, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
  • IEC 60601-1-8:2006+AMD1:2012 CSV, 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 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

3.Европын стандартчиллын байгуулллага (CEN)

(хамгаалах хэрэгслийн 11 стандартыг CEN-гишүүн байгууллагуудын вэб хаягаас танилцах боломжтой)

  • EN 149:2001 + A1:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as ‘FFP masks’)
  • EN 14683:2019 Medical face masks - Requirements and test methods
  • EN 166:2001 Personal eye-protection – Specifications
  • EN 14126:2003 + AC 2004 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
  • EN 14605:2009 + A1:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only
  • EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
  • EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
  • EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
  • EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
  • EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
  • EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)

4.Хятадын стандартын байгууллага (SAC)

(Доор дурдсан стандарт, Европын стандарттай харьцуулсан судалгааг стандарт боловсруулах албан хэрэгцээнд зориулан англи хэлээр ирүүлсэн)

GB 2626—2019 Respiratory protection-Non-powered air-purifying particle respirator

GB14866—2006 The specifications for personal eye-protectors

GB 19082—2009 Technical Requirements for Single-use Protective Clothing for Medical Use

GB 19083-2010 Technical requirements for protective face mask for medical use

GB 24788—2009 Limit for the removable surface powder and water-extractable protein of medical gloves

GB/T 18664—2002 Selection, use and maintenance of respiratory protective equipment

GB/T 24787—2009 Single-use non-sterile rubber surgical gloves

GB/T 32610-2016 Technical specification of daily protective mask

YY 0469-2011 Surgical Mask

5.Материалын сорилт туршилтын Америкийн нийгэмлэг (ASTM)

(Хамгаалах хувцас, ариутгалын бодисны холбогдолтой 20 гаруй стандартыг https://www.astm.org/COVID-19/ хаягаас уншиж танилцах боломжтой)

  • ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
  • ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
  • ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
  • ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
  • ASTM F1494-14 Standard Terminology Relating to Protective Clothing
  • ASTM F2407 - 06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
  • ASTM F1671 / F1671M - 13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
  • ASTM F1868 - 17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
  • ASTM D751 - 19 Standard Test Methods for Coated Fabrics
  • ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics
  • ASTM D1776/D1776M-20 Standard Practice for Conditioning and Testing Textiles
  • ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
  • ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
  • ASTM D5733 - 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008)
  • ASTM D6701-16 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
  • ASTM F1494-14 Standard Terminology Relating to Protective Clothing
  • ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
  • ASTM D3578-19 Standard Specification for Rubber Examination Gloves
  • ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
  • ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application
  • ASTM E2755-15 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults
  • ASTM E1174-13 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
  • ASTM E3058-16 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations
  • ASTM F3387-19 Standard Practice for Respiratory Protection

Олон нийтийн сүлжээнд хуваалцах