ANSI AAMI ISO 16142-1-2016 pdf download
ANSI AAMI ISO 16142-1-2016 pdf download.Medical devices—Recognized essential principles of safety and performance of medical devices
1 Scope
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic). This part of ISO 16142 also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to medical devices other than IVD medical devices. Future ISO 16142-2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process of IVD medical devices. NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others. This part of ISO 16142 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1135 (all parts), Transfusion equipment for medical use
ISO 3107, Dentistry—Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
ISO 3826 (all parts), Plastics collapsible containers for human blood and blood components
ISO 5356 (all parts), Anaesthetic and respiratory equipment—Conical connectors
ISO 5359, Anaesthetic and respiratory equipment—Low-pressure hose assemblies for use with medical gases
ISO 5360, Anaesthetic vaporizers—Agent-specific filling systems
ISO 5361:— 1 , Anaesthetic and respiratory equipment—Tracheal tubes and connectors
ISO 5362, Anaesthetic reservoir bags
ISO 5364, Anaesthetic and respiratory equipment—Oropharyngeal airways
ISO 5366 (all parts), Anaesthetic and respiratory equipment—Tracheostomy tubes
ISO 5367, Anaesthetic and respiratory equipment—Breathing sets and connectors
ISO 5832 (all parts), Implants for surgery—Metallic materials
ISO 5834 (all parts), Implants for surgery—Ultra-high-molecular-weight polyethylene
ISO 5838 (all parts), Implants for surgery—Metallic skeletal pins and wires
ISO 5840 (all parts), Cardiovascular implants—Cardiac valve prostheses
ISO 5841 (all parts), Implants for surgery—Cardiac pacemakers
ISO 6474-1, Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina
ISO 7000, Graphical symbols for use on equipment—Registered symbols
ISO 7010, Graphical symbols—Safety colours and safety signs—Registered safety signs
ISO 7153-1, Surgical instruments—Metallic materials—Part 1: Stainless steel
ISO 7197, Neurosurgical implants—Sterile, single-use hydrocephalus shunts and components
ISO 7198, Cardiovascular implants—Tubular vascular prostheses
ISO 7199, Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)
ISO 7206 (all parts), Implants for surgery—Partial and total hip joint prostheses
ISO 7207 (all parts), Implants for surgery—Components for partial and total knee joint prostheses
ISO 7376, Anaesthetic and respiratory equipment—Laryngoscopes for tracheal intubation
ISO 7396 (all parts), Medical gas pipeline systems
ISO 7405, Dentistry—Evaluation of biocompatibility of medical devices used in dentistry
SO 8537, Sterile single-use syringes, with or without needle, for insulin
ISO 8637, Cardiovascular implants and extracorporeal systems—Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8638, Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for haemodialysers,haemodiafilters and haemofilters
ISO 8827, Implants for surgery—Staples with parallel legs for orthopaedic use—General requirements
ISO 8828, Implants for surgery—Guidance on care and handling of orthopaedic implants
ISO 8835-7, Inhalational anaesthesia systems—Part 7: Anaesthetic systems for use in areas with limited logistical
supplies of electricity and anaesthetic gases
ISO 9168, Dentistry—Hose connectors for air driven dental handpieces
ISO 9170 (all parts), Terminal units for medical gas pipeline systems
