ISO 13485:2013 is an international standard for medical devices that says what needs to be done to ensure the quality of medical devices. ISO 13485 is based on risk-based design and ensures that medical devices are safe and effective. It establishes minimum requirements for medical device design...
The standard ensures that your medical products consistently meet customer expectations of quality, safety, and performance. The ISO 13485:2016 edition of the standard builds on the ISO 9001 standard, and it includes additional regulatory requirements for the medical device industry. Following the last...
Intertek Academy learning helps you understand, implement, and improve your business with management systems and compliance training. Go To Intertek Academy SAHPRA Recognized QMS Certificates Intertek Medical Notified Body AB has registered with SAPHRA in recognition of SWEDAC accredited ISO 13485 certificat...
Thisdocumentspecifiesgeneralrequirementsforevaluatingtheinteractionsofmedicaldeviceswithblood. 本文件规定了评估医疗器械与血液相互作用的一般要求。 Itdescribes 它描述了 a)aclassificationofmedicaldevicesthatareintendedforuseincontactwithblood,basedontheintendeduseand durationofcontactasdefinedinISO10993-1, a)根据ISO10...
ISO 10993-1-2018中文,医疗器械的生物评价.第1部分.pdf,ISO 10993-1:2018(E) 中英文版 INTERNATIONAL Fifth edition 第5版 STANDARD 2018-08 国际标准 Biological evaluation of medical devices —Part 1:Evaluation and testing within a risk management process 医疗器
ISO 13485 is hugely important to designers, manufacturers, and distributors of medical devices. Adopting this standard provides an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and respons...
ISO 13485 is hugely important to designers, manufacturers, and distributors of medical devices. Adopting this standard provides an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and respons...
ISO 10993-10-2021中文+英文,医疗器械的生物评价.第10部分.pdf,ISO 10993-10:2021(E) 中英文版 INTERNATIONAL Fourth edition 第4版 STANDARD 2021-11 国际标准 Biological evaluation of medical devices — Part 10:Tests for skin sensitization 医疗器械生物学评价— 第
INTERNATIONAL ISO STANDARD 15223-1 Third edition 2016-11-01 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l’étiquetage et les ...
doi:10.1097/00134384-200403000-00003Libeer, Jean-ClaudeEhrmeyer, SharonPoint of Care The Journal of Near-Patient Testing & TechnologyLibeer JC, Ehrmeyer S. ISO 15189: A worldwide stan- dard for medical laboratories. Point of Care 2004; 3: 5-7....