Menu
Public Comments on Draft Saint Lucia National Standards
The following draft standards are being proposed for adoption as Saint Lucia National Standards:
Electronic Data in Health Care
DNS/ISO/TR 13054 Knowledge management of health information standards
General
- DNS/ISO 21998:2020 Interpreting services — Healthcare interpreting — Requirements and recommendation
- DNS/ISO 12749-6: 2020 Nuclear energy, nuclear technologies, and radiological protection — Vocabulary — Part 6: Nuclear medicine
- DNS/ISO 22956:2021 Healthcare organization management — Requirements for patient-centered staffing
- DNS/ISO 22886:2020 Healthcare organization management — Vocabulary
- DNS/ISO 5472: 2022 Healthcare organization management — Pandemic response (respiratory) — Walk-through screening station
- DNS/ISO 5258: 2022 Healthcare organization management — Pandemic response (respiratory) — Drive-through screening station
- DNS/ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
- DNS/ISO 23907-1: 2019 Sharps injury protection — Requirements and test methods — Part 1: Single-use sharps containers
- DNS/ISO 23907-2: 2019 Sharps injury protection — Requirements and test methods — Part 2: Reusable sharps containers
- DNS/ISO 23908: 2011 Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- DNS/IWA 35:2020 Quality of learning environments for students in healthcare professions — Requirements for healthcare education providers in care settings
- DNS/ISO 25551:2021 Ageing societies — General requirements and guidelines for career-inclusive organizations
- DNS/ISO 7886-3:2020 Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization
- DNS/ISO/IEC Guide 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
- DNS/ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
- DNS/ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
- DNS/ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
- DNS/ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
- DNS/ISO 25552:2022 Ageing societies — Framework for dementia-inclusive communities
Laboratory
- DNS/ISO 15189: 2022 Medical Laboratories – Requirements for Quality and Competence (ISO 15189: 2022, IDT)
- DNS/ISO 15190: 2020 Medical Laboratories — Requirements for Safety (ISO 15190: 2020, IDT)
- DNS/ISO/TS 17518: 2015 Medical Laboratories — Reagents for Staining Biological Material — Guidance for Users (ISO 17518: 2015, IDT)
- DNS/ISO 22367: 2020 Medical Laboratories-Application of Risk Management to Medical Laboratories (ISO 22367: 2020)
Medical Equipment
- DNS/ISO_32_1977 Gas Cylinders for Medical Use
- DNS/ISO_4135_2022 Anaesthetic and respiratory equipment
- DNS/ISO_10282_2023 Single-Use sterile Rubber Surgical Gloves
- DNS/ISO_11193-1_2020 Single Use Medical Examination Gloves-Part 1
- DNS/ISO_11193-2_2006 Single Use Medical Examination
- DNS/ISO/IEC GUIDE 63: 2019 Guide To The Development and Inclusion of Aspects of Safety In International Standards For Medical Devices (ISO /IEC GUIDE 63: 2019, IDT)
- DNS/ISO 15223-1: 2021 Medical Devices — Symbols to be used with Information to be Supplied by The Manufacturer —Part 1: General Requirements (ISO 15223-1: 2021, IDT)
- DNS/ISO 15223-2: 2010 Medical Devices, Symbols to be used with Medical Device Labels, Labelling, and Information to be Supplied – Part 2: Symbol Development, Selection and Validation (ISO 15223-2: 2010, IDT)
- DNS/ISO 15378: 2017 Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application Of ISO 9001: 2015, with Reference to Good Manufacturing Practice (GMP) (ISO 15378: 2017, IDT)
- DNS/ISO_20069_2019 Guidance for Assessment and Evaluation to Drug Delivery Systems
- DNS/ISO_20417_2021 Medical Devices-Information to be supplied by the manufacturer
Ophthalmology
- DNS/ISO_7998_2005 Ophthalmic Optics
- DNS/ISO_8429_1986 Optics and Optical Instruments
- DNS/ISO_8596_2017 Ophthalmic Optics-Visual Acuity Testing
- DNS/ISO_8598-1_2014 Optics and Optical Instruments-Focimeters-Part 1
- DNS/ISO_8624_2020 Ophthalmic Optics-Spectacle Frames
- DNS/ISO_8980-1_2017 Ophthalmic Optics-Uncut finished Spectacle Lenses
- DNS/ISO_8980-2_2017 Ophthalmic Optics-Uncut Spectacle Lenses
- DNS/ISO_8980-5_2005 Ophthalmic Optics-Uncut Finished Spectacle Lenses
- DNS/ISO_9342-1_2005 Test lenses for Calibration of Focimeters Part 1
- DNS/ISO_9342-2_2005 Test Lenses for Calibration of Focimeters-Part 2
- DNS/ISO_9801_2009 Ophthalmic Instruments-Trial Case Lenses
- DNS/ISO_10322-1_2016 Ophthalmic Optics-Semi-Finished Lens
- DNS/ISO_10322-2_2016 Ophthalmic Optics-Specifications for Progressive and Degressive Lens
- DNS/ISO_10341_2012 Ophthalmic Instruments-Refractor Heads
- DNS/ISO_10342_2010 Ophthalmic Instruments-Eye Refractometers
- DNS/ISO_10343_2014 Ophthalmometers
- DNS/ISO_10938_2016 Ophthalmic Optics-Chart Displays for Visual Acuity
- DNS/ISO_10939_2017 Ophthalmic -Slit Lamp Microscopes
- DNS/ISO_10940_2009 Ophthalmic Fundus Cameras
- DNS/ISO_10942_2022 Direct Ophthalmoscopes
- DNS/ISO_10943_2023 Indirect Ophthalmoscopes
- DNS/ISO_10944_2009 Synoptophores
- DNS/ISO_14534_2011 Contact Lenses -Fundamental Requirements
- DNS/ISO_18369-1_2017 Contact Lenses-Vocabulary, Classification
Quality and Environmental
- DNS/ISO 5258: 2022 Healthcare Organization Management — Pandemic Response (Respiratory) — Drive-Through Screening Station (ISO 5258: 2022, IDT)
- DNS/ISO 5472: 2022 Healthcare Organization Management — Pandemic Response (Respiratory) — Walk-Through Screening Station (ISO 5472: 2022, IDT)
- DNS/ISO 22886: 2020 Healthcare Organization Management—Vocabulary (ISO 22886: 2020, IDT)
- DNS/ISO 22956: 2021 Healthcare Organization Management—Requirements for Patient-Centred Staffing (ISO 22956: 2021, IDT)
- DNS/ISO 10012: 2015 Measurement Management Systems — Requirements for Measurement Processes and Measuring Equipment (ISO 10012: 2015, IDT)
- DNS/ISO 13485: 2016 Medical Devices— Quality Management Systems—Requirements for Regulatory Purposes (ISO 13485: 2016, IDT)
Sterilization and Disinfectant
- DNS/ISO/TS 5111: 2022 Guidance On Quality of Waters for Sterilizers, Sterilization and Washer-Disinfectors for Health Care Products (ISO/TS 5111: 2022, IDT)
- DNS/ISO 11135: 2014 Sterilization of Health-Care Products— Ethylene Oxide—Requirements for The Development, Validation and Routine Control of a Sterilization Process for Medical Devices (ISO 11135: 2014, IDT)
Wheelchairs
DNS/ISO 7176-1: 2014 Wheelchairs — Part 1: Determination of Static Stability (ISO 7176-1: 2014,IDT)
DNS ISO 7176-3 2012 Wheelchairs -Determination of Effectiveness of Brakes
DNS ISO 7176-4 2008 Wheelchairs – Energy Consumption of Electric Wheelchairs and Scooters
DNS ISO 7176-5 2008 Determination of Dimensions
DNS ISO 7176-6 2018 Wheelchairs – Speed of Electrically Powered
DNS ISO 7176-7 1998 Wheelchairs – Measurement of Seating and Wheel Dimensions
DNS ISO 7176-8 2014 Requirements and Test Methods for Static Impact and Failure Strength
DNS ISO 7176-9 2009 Wheelchairs – Climatic Tests for Electric Wheelchairs
DNS ISO 7176-10 2008 Determination of Obstacle Climbing Ability of Electrically Powered Wheelchairs
DNS ISO 7176-11:2012 Wheelchairs —Part 11: Test Dummies
DNS ISO 7176-13 :1989 Wheelchairs Part 13 Determination of Coefficient of Friction of Test Surfaces
DNS ISO 7176-19:2022 Wheelchairs — Part 19: Wheelchairs for use as Seats in Motor Vehicles DNS
DNS ISO 7176-22:2014 Wheelchairs — Part 22: Set-up Procedures
DNS ISO 7176-26:2007 Wheelchairs — Part 26: Vocabulary
DNS ISO 7176-28:2012 Wheelchairs Part 28:Requirements and Test Methods for Stairclimbing Devices
DNS ISO 7176-32:2022 Wheelchairs — Part 32: Test Method for Wheelchair Castor Assembly Durability
DNS ISO 9386-1:2000 Power-Operated Lifting Platforms for Persons with Impaired Mobility — Rules for Safety, Dimensions and Functional Operation —Part 1: Vertical Lifting Platforms
Passengers —Part 1: Systems for Rearward-Facing Wheelchair Seated Passengers
Passengers — Part 2: Systems for Forward-Facing Wheelchair-Seated Passengers
DNS ISO 16840-4:2009 Wheelchair Seating — Part 4: Seating Systems for Use in Motor Vehicles
DNS ISO 19894:2019 Walking Trolleys — Requirements and Test Methods
The deadline for comments on the above standards is Monday 14th October, 2024.