Persyaratan Mutu Peralatan Medis Afrika Selatan   

Regulasi Peralatan Medis.

 

Ketentuan Impor.

  • Secara umum memerlukan Letter of Approval dari SABS (GN R.1792/1996 Standards Act 29/1983)
  • Peralatan Orthopedi memerlukan Izin dari Ditjen: National Health and Population Development (Dental Mechanicians Act 30/1947 GN 1186/1966)
  • Peralatan dengan penggunaan sinar-X atau alpha, radiasi beta atau gamma memerlukan Izin dari Ditjen: National Health and Population Development (Nuclear Energy Act No. 92/1982 dan GN R.1792/1996 Standards Act 29/1983)
 

Standar Peralatan Medis.

  • SANS 60601-1-11 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
  • SANS 60601-2-2:2019 (Ed. 2.00) Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  • SANS 60601-2-10:2018 (Ed. 2.00) Medical electrical equipment -Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
  • SANS 60601-2-43:2019 (Ed. 1.01) Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
  • SANS 60601-2-54:2019 (Ed. 1.00) Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • SANS 60601-2-65:2019 (Ed. 1.01) Medical electrical equipment Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
  • SANS 60601-2-63:2019 (Ed. 1.01) Medical electrical equipment Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
  • SANS 11137-1 Sterilization of health care products - Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • SANS 17665-1 Sterilization of health care products - Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
  • SANS 11135-1 Sterilization of health care products - Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • SANS 60598-2-25:1994 (Ed. 1.00) Luminaires Part 2-25: Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings
  • SANS 1384:2006 (Ed. 2.00) Plastics containers for parenteral solutions
  • SANS 10331:2000 (Ed. 1.00) Translocation of certain species of wild herbivore
  • SANS 51616:1997 (Ed. 1.00) Sterile urethral catheters for single use
  • SANS 1271:1999 (Ed. 3.00) Mepivacaine hydrochloride injection for dental use
  • SANS 2631-1:1997 (Ed. 1.00) Mechanical vibration and shock - Evaluation of human exposure to whole-body vibration Part 1: General requirements
  • SANS 8362-1:1989 (Ed. 1.00) Injection containers for injectables and accessories Part 1: Injection vials made of glass tubing
  • SANS 1233:1993 (Ed. 2.00) The production of a balanced solution of electrolytes for injection
  • SANS 8253-3:1996 (Ed. 1.00) Acoustics - Audiometric test methods Part 3: Speech audiometry
  • SANS 1232:1993 (Ed. 2.00)The production of sodium bicarbonate injections of various strengths
  • SANS 1775:1999 (Ed. 1.00) Sterile single-use intravenous (IV) infusion sets (administration sets)
  • SANS 6109:1988 (Ed. 1.00) Volume of gas in a cartridge
  • SANS 491:1996 (Ed. 3.00) Wooden crutches
  • CKS 183:1969 (Ed. 1.00) Inflatable splints (polyvinyl chloride)
  • SANS 1593:1994 (Ed. 1.00)Disinfectants based on glutaraldehyde for use on medical instruments
  • SANS 5004:1987 (Ed. 3.00) Sterility of antibiotics and preparations containing antibiotics
  • SANS 6025:1984 (Ed. 1.00) Vinyl chloride monomer content of polyvinyl chloride plastics for medical use
  • SANS 5591:1975 (Ed. 1.00) Preparation of samples and extracts used in testing plastics for medical use
  • SANS 5006:1992 (Ed. 4.00) Pyrogenicity of pharmaceutical products (derived from BP 1988)
  • VC 8041:2001 (Ed. 2.00) Microbiological safety cabinets (Classes I, II and III)
  • CKS 225:1970 (Ed. 1.00) Envelopes for X-ray films
  • SANS 1231:1993 (Ed. 2.00)The production of half-concentrated Darrow's solution with dextrose for injections
  • SANS 1523:1990 (Ed. 1.00) Sheepskins (for medical use)
  • SANS 50455-4:2019 (Ed. 1.00) Medical gloves for single use Part 4: Requirements and testing for shelf life determination
  • SANS 50455-3:2019 (Ed. 1.00) Medical gloves for single use Part 3: Requirements and testing for biological evaluation
  • SANS 50455-2:2019 (Ed. 1.00) Medical gloves for single use Part 2 - Requirements and testing for physical properties
  • SANS 50455-1:2019 (Ed. 1.00) Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
  • SANS 433:2019 (Ed. 2.01) Barrier creams
  • CKS 209:1977 (Ed. 2.00) Medicine spoon (plastics)
  • SANS 11737-1:2019 (Ed. 1.00) Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products
  • SANS 11137-3:2019 (Ed. 2.00) Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
  • SANS 11138-1:2018 (Ed. 3.00) Sterilization of health care products - Biological indicators Part 1: General requirements
  • SANS 11140-1:2018 (Ed. 2.00) Sterilization of health care products - Chemical indicators Part 1: General requirements
  • SANS 1188:1978 (Ed. 1.00) Production of single-use hypodermic needles (sterile-packed) for dental cartridge syringes
  • SANS 6266:2017 (Ed. 1.02 )Virucidal efficacy of disinfectants and detergent-disinfectants using bacteriophages as indicator organisms
 
Tautan standar peralatan medis:
https://store.sabs.co.za/manufacturing/medical-pharmaceutical?id=67&p=5