The Department of Trade and Industry’s Bureau of Philippine Standards (DTI-BPS) informs its stakeholders that all Medical Personal Protective Equipment (PPE) or emergency response related Philippine National Standards (PNS) shall be provided for FREE to any interested entity or stakeholder. The initiative supports the national government’s efforts in dealing with the Corona Virus Disease (COVID-19) crisis. The International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) versions are also currently freely available in read-only format at the ISO website https://www.iso.org/covid19 and https://webstore.iec.ch/webstore/webstore.nsf/xpFAQ.xsp?OpenXPage&id=GFOTBNAEXA.

The following PNS, which are direct adoption of the ISO and IEC versions are now available at the BPS Standards Data Center:

PROTECTIVE CLOTHING

PNS NS EN 13795-1:2020 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns (NS EN published 2019)


PNS NS EN 13795-2:2020 Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits (NS EN published 2019)


PNS NS EN 14126:2020 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents (NS EN published 2003 with Corrigendum AC:2004)


PNS NS EN 14605:2020 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 (Types PB [3] and PB [4]) (NS EN published 2009 with Amendment 1:2009)


PNS ISO/TR 11610:2020 Protective clothing – Vocabulary (ISO published 2004)


PNS ISO 19918:2020 Protective clothing – Protection against chemicals – Measurement of cumulative permeation of chemicals with low vapour pressure through materials (ISO published 2017)


PNS ISO 22610:2020 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment – Test method to determine the resistance to wet bacterial penetration (ISO published 2018)


PNS ISO 13688:2015 Protective clothing – General requirements (ISO published 2013)


PNS ISO 6530:2015 Protective clothing – Protection against liquid chemicals – Test method for resistance of materials to penetration by liquids (ISO published

 

PNS ISO 13982-1:2015 Protective clothing for use against solid particulates – Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing)


PNS ISO 13994:2015 Clothing for protection against liquid chemicals – Determination of the resistance of protective clothing materials to penetration by liquids under pressure


PNS ISO 16602:2015 Protective clothing for protection against chemicals – Classification, labelling and performance requirements


PNS ISO 16603:2015 Clothing for protection against contact with blood and body fluids – Determination of the resistance of protective clothing materials to penetration by blood and body fluids – Test method using synthetic blood


PNS ISO 16604:2015 Clothing for protection against contact with blood and body fluids – Determination of resistance of protective clothing materials to penetration by blood-borne pathogens – Test method using Phi-X 174 bacteriophage


PNS ISO 22612:2015 Clothing for protection against infectious agents – Test method for resistance to dry microbial penetration

MEDICAL GLOVES


PNS NS EN 455-1:2020 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes (NS EN published 2000)


PNS NS EN 455-2:2020 Medical gloves for single use – Part 2: Requirements and testing for physical properties (NS EN published 2015)


PNS NS EN 455-3:2020 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation (NS EN published 2015)

 

PNS NS EN 455-4:2020 Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (NS EN published 2009)


PNS ISO 374-1:2020 Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks (ISO published 2016 with Amendment 1:2018)


PNS ISO 374-2:2020 Protective gloves against dangerous chemicals and micro-organisms – Part 2: Determination of resistance to penetration (ISO published 2019)


PNS ISO 374-4:2020 Protective gloves against dangerous chemicals and micro-organisms – Part 4: Determination of resistance to degradation of chemicals (ISO published 2019)


PNS ISO 374-5:2020 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks (ISO published 2016)


PNS ISO 21420:2020 Protective gloves – General requirements and test methods (ISO published 2020)

FACE MASKS / RESPIRATORY PROTECTIVE DEVICE (RPD)

PNS NS EN 149:2020 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (NS EN published 2001 with Amendment 1:2009)


PNS NS EN 14683:2020 Medical face masks – Requirements and test methods (NS EN published 2019)


PNS ISO 22609:2015 Clothing for protection against infectious agents – Medical face masks – Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) (ISO 22609:2004)

 

PNS ISO/TS 16976-8:2020 Respiratory protective devices — Human factors — Part 8: Ergonomic factors (ISO published 2013)

OTHER RPD STANDARDS

PNS ISO 16900-1:2020 Respiratory protective devices — Methods of test and test equipment — Part 1: Determination of inward leakage


PNS ISO 16900-2:2020 Respiratory protective devices — Methods of test and test equipment — Part 2: Determination of breathing resistance

PNS ISO 16900-3:2020 Respiratory protective devices — Methods of test and test equipment — Part 3: Determination of particle filter penetration


PNS ISO 16900-4:2020 Respiratory protective devices — Methods of test and test equipment — Part 4: Determination of gas filter capacity and migration, desorption and carbon monoxide dynamic testing


PNS ISO 16900-5:2020 Respiratory protective devices — Methods of test and test equipment — Part 5: Breathing machine, metabolic simulator, RPD headforms and torso, tools and verification tools


PNS ISO 16900-6:2020 Respiratory protective devices — Methods of test and test equipment — Part 6: Mechanical resistance/strength of components and connections

PNS ISO 16900-7:2020 Respiratory protective devices — Methods of test and test equipment — Part 7: Practical performance test methods


PNS ISO 16900-8:2020 Respiratory protective devices — Methods of test and test equipment — Part 8: Measurement of RPD air flow rates of assisted filtering RPD


PNS ISO 16900-9:2020 Respiratory protective devices — Methods of test and test equipment — Part 9: Determination of carbon dioxide content of the inhaled gas


PNS ISO 16900-10:2020 Respiratory protective devices — Methods of test and test equipment — Part 10: Resistance to ignition, flame, radiant heat and heat

 

PNS ISO 16900-11:2020 Respiratory protective devices — Methods of test and test equipment — Part 11: Determination of field of vision


PNS ISO 16900-12:2020 Respiratory protective devices — Methods of test and test equipment — Part 12: Determination of volume-averaged work of breathing and peak respiratory pressures


PNS ISO 16900-13:2020 Respiratory protective devices — Methods of test and test equipment — Part 13: RPD using regenerated breathable gas and special application mining escape RPD: Consolidated test for gas concentration, temperature, humidity, work of breathing, breathing resistance, elastance and duration


PNS ISO 16900-14:2020 Respiratory protective devices — Methods of test and test equipment — Part 14: Measurement of sound level


PNS ISO 16972:2020 Respiratory protective devices — Terms, definitions, graphical symbols and units of measurement


PNS ISO/TS 16973:2020 Respiratory protective devices — Classification for respiratory protective device (RPD), excluding RPD for underwater application


PNS ISO/TS 16974:2020 Respiratory protective devices — Marking and information supplied by the manufacturer


PNS ISO 16975-3:2020 Respiratory protective devices — Selection, use and maintenance — Part 3: Fit-testing procedures


PNS ISO/TS 16975-1:2020 Respiratory protective devices — Selection, use and maintenance — Part 1: Establishing and implementing a respiratory protective device programme


PNS ISO/TS 16975-2:2020 Respiratory protective devices — Selection, use and maintenance — Part 2: Condensed guidance to establishing and implementing a respiratory protective device programme

 

PNS ISO/TS 16976-1:2020 Respiratory protective devices — Human factors — Part 1: Metabolic rates and respiratory flow rates


PNS ISO/TS 16976-2:2020 Respiratory protective devices — Human factors — Part 2: Anthropometrics


PNS ISO/TS 16976-3:2020 Respiratory protective devices — Human factors — Part 3: Physiological responses and limitations of oxygen and limitations of carbon dioxide in the breathing environment


PNS ISO/TS 16976-4:2020 Respiratory protective devices — Human factors — Part 4: Work of breathing and breathing resistance: Physiologically based limits


PNS ISO/TS 16976-5:2020 Respiratory protective devices — Human factors — Part 5: Thermal effects


PNS ISO/TS 16976-6:2020 Respiratory protective devices — Human factors — Part 6: Psycho-physiological effects


PNS ISO/TS 16976-7:2020 Respiratory protective devices — Human factors — Part 7: Hearing and speech


PNS ISO 17420-3:2020 Respiratory protective devices — Performance requirements — Part 3: Thread connection

EYE PROTECTION

PNS NS EN 166:2020 Personal eye-protection –Specifications (NS EN published 2001)

SECURITY AND RESILIENCE/RISK MANAGEMENT

PNS ISO 22301:2020 Security and resilience – Business continuity management systems –Requirements (ISO published 2019)

 

PNS ISO 22395:2020 Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency (ISO Published 2018)


PNS ISO 22320:2018 Security and resilience – Emergency management – Guidelines for incident management (ISO Published 2018) (ISO Published 2018)


PNS ISO 22316:2018 Security and resilience – Organizational resilience – Principles and attributes (ISO Published 2017)


PNS ISO 31000:2018 Risk management – Guidelines (ISO published 2018)

ANAESTHETIC AND RESPIRATORY EQUIPMENT

PNS ISO 10651-3:2020 Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators (ISO published 1997)


PNS ISO 10651-4:2020 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO published 2002)


PNS ISO 10651-5:2020 Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators (ISO published 2006)


PNS ISO 17510:2020 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories (ISO published 2015)


PNS ISO 18082:2020 Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
(ISO published 2014 with Amendment 1:2017)


PNS ISO 18562-1:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process (ISO published 2017)

 

PNS ISO 18562-2:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter (ISO published 2017)


PNS ISO 18562-3:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO published 2017)


PNS ISO 18562-4:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate (ISO published 2017)


PNS ISO 19223:2020 Lung ventilators and related equipment — Vocabulary and semantics (ISO published 2019)


PNS ISO 5356-1:2020 Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO published 2015)

BIOLOGICAL EVALUATION OF MEDICAL DEVICES

PNS ISO 10993-1:2020 Biological evaluation of medical devices — Part 1:

Evaluation and testing within a risk management process (ISO published 2018)

QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

PNS ISO 13485:2019 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO published 2016)

BIOTECHNOLOGY

PNS ISO 20395:2020 Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR (ISO published 2019)

MEDICAL ELECTRICAL EQUIPMENT

PNS ISO 80601-2-12:2020 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO published 2020)


PNS ISO 80601-2-13:2020 Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO published 2011 with Amendment 1:2015 and Amendment 2:2018 )


PNS ISO 80601-2-70:2020 Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO published 2015)


PNS ISO 80601-2-74:2020 Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO published 2017)


PNS ISO 80601-2-79:2020 Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO published 2018)


PNS ISO 80601-2-80:2020 Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO published 2018)


PNS IEC 60601-1:2016 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC published 2005 with Amendment 1:2012)


PNS IEC 60601-1-2:2020 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests (IEC published 2014)

 

PNS IEC 60601-1-6:2020 Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance – Collateral standard: Usability (IEC published 2010 with Amendment 1:2013)


PNS IEC 60601-1-8:2020 Medical electrical equipment – Part 1-8: General requirements forbasic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems (IEC published 2006 with Amendment 1:2012)


PNS IEC 60601-1-11:2020 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 (IEC published 2015)


PNS IEC 80601-2-72:2020 Medical electrical equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients


PNS IEC 60601-1:2016 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance


The DTI-BPS, as the country’s National Standards Body, is the official member representative of the Philippines to the ISO and the International Electrotechnical Commission (IEC). To request for the free copy of the standards, kindly coordinate directly at telephone numbers (02)7791.3127 or email us at bps@dti.gov.ph or standardsdatacenterbps@dti.gov.ph. For more information on standards and standardization, please visit the DTI-BPS Portal at http://www.bps.dti.gov.ph/ and follow our Facebook Page https://www.facebook.com/phstandards/. You may also call the agency at (02)7751.4700.♦

Date of Release: 22 April 2020