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STANDARDS

Controlled and standardised quality

The reference documents used by THERMOFINA to guarantee the quality of its products and services are:

Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes

Relative to medical devices, incorporated into French law by Decree 95.292 of 16/03/1995 of the French Public Health Code

 

ISO 13485

European Directive 93/42/EEC

Relative to equipment monitoring of medical devices

Symbols used in medical device labelling

Information supplied by the manufacturer with the medical devices

Application of risk management to medical devices

Medical gloves for single use – Requirements and testing for freedom from holes

Medical gloves for single use – Requirements and testing for physical properties

Medical gloves for single use – Requirements and testing for biological evaluation

Medical gloves for single use – Requirements and testing for shelf life determination

Protective gloves against chemicals and micro-organisms – Terminology and performance requirements

Protective gloves against hazardous chemicals and micro-organisms – Determination of resistance to penetration

Protective gloves against chemicals and micro-organisms – Determination of resistance to permeation by chemicals

Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

Performance of ear thermometers (with maximum device)

Non-invasive sphygmomanometers – General requirements

Non-invasive sphygmomanometers – Supplementary requirements for electromechanical blood pressure measuring systems

Urine collection bags – Vocabulary

Urine collection bags – Requirements and test methods

 

  Decree n. 96-32

EN 980

EN 1041

ISO 14971

EN 455-1

EN 455-2

EN 455-3

EN 455-4

EN 374-1

EN 374-2

EN 374-3

EN 12470-3

EN 12470-5

EN 1060-1

EN 1060-3

ISO 8669-1

ISO 8669-2

 

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THERMOFINA © 2015

THERMOFINA

THERMOFINA has manufactured and distributed sterile and non-sterile medical devices for over 50 years.
This sector requires vigilance and precision in order to constantly offer technical products that perfectly meet the requirements of your business in terms of functionality, reliability and hygiene.

 

MEDICAL DEVICES

Z.A.C Chamlys - B.P. 130

77194 Dammarie-lès-Lys Cedex - France

Tel : +33 (0) 1 64 37 81 96

Fax : +33 (0) 1 64 37 08 77

Email : thermofina@thermofina.fr

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