SFS-EN ISO 22523:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
06 03 - 06 15 Orthoses06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements

4.1 Risk management
4.2 Intended performance and technical documentation
4.3 Clinical evaluation
4.4 Strength and related conditions of use

5 Requirements for materials

5.1 Flammability of materials and toxicity of combustion products
5.2 Biocompatibility, contaminants and residues
5.3 Infection and microbiological contamination
5.4 Resistance to corrosion and degradation

6 Noise and vibration
7 Electromagnetic compatibility (EMC)
8 Electrical safety

8.1 Battery-powered prosthetic and orthotic devices
8.2 Circuit protection
8.3 Electronic programmable systems
8.4 Electrically heated blankets, pads and similar flexible heating appliances
8.5 Prosthetic and orthotic devices with skin contact electrodes 1)
8.6 Prosthetic and orthotic devices with radio equipment

9 Surface temperature
10 Sterility
11 Design requirements

11.1 Safety of moving parts
11.2 Safety of connections

12 Mechanical requirements

12.1 Restrictions on use
12.2 Forces in soft tissues of the human body
12.3 Ergonomic principles

13 Information supplied by the manufacturer

13.1 General
13.2 Labelling
13.3 Intended use

14 Packaging

Annex A Guidance on methods of determining the strength of upper-limb prosthetic devices (informative)
Annex B Method of determining the mechanical properties of knee joint assemblies for lower-limb orthotic devices (normative)
Annex C Guidance on methods of determining the flammability and toxicity of combustion products of lower-limb prosthetic devices (informative)
Annex D Guidance on methods of establishing the force or moment required to operate the control and actuating mechanisms on prosthetic and orthotic devices (informative)
Annex E Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142 (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements

4.1 Risk management
4.2 Intended performance and technical documentation
4.3 Clinical evaluation
4.4 Strength and related conditions of use

5 Requirements for materials

5.1 Flammability of materials and toxicity of combustion products
5.2 Biocompatibility, contaminants and residues
5.3 Infection and microbiological contamination
5.4 Resistance to corrosion and degradation

6 Noise and vibration
7 Electromagnetic compatibility (EMC)
8 Electrical safety

8.1 Battery-powered prosthetic and orthotic devices
8.2 Circuit protection
8.3 Electronic programmable systems
8.4 Electrically heated blankets, pads and similar flexible heating appliances
8.5 Prosthetic and orthotic devices with skin contact electrodes 1)
8.6 Prosthetic and orthotic devices with radio equipment

9 Surface temperature
10 Sterility
11 Design requirements

11.1 Safety of moving parts
11.2 Safety of connections

12 Mechanical requirements

12.1 Restrictions on use
12.2 Forces in soft tissues of the human body
12.3 Ergonomic principles

13 Information supplied by the manufacturer

13.1 General
13.2 Labelling
13.3 Intended use

14 Packaging

Annex A Guidance on methods of determining the strength of upper-limb prosthetic devices (informative)
Annex B Method of determining the mechanical properties of knee joint assemblies for lower-limb orthotic devices (normative)
Annex C Guidance on methods of determining the flammability and toxicity of combustion products of lower-limb prosthetic devices (informative)
Annex D Guidance on methods of establishing the force or moment required to operate the control and actuating mechanisms on prosthetic and orthotic devices (informative)
Annex E Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142 (informative)

Bibliography

Tuoteryhmä(t)

11.040.40 Kirurgiset implantit, proteesit ja ortoosit »

Sidokset

Velvoittavat viittaukset

EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN IEC 61000-6-2:2019 Sähkömagneettinen yhteensopivuus (EMC). Osa 6-2: Yleiset standardit. Häiriönsieto teollisuusympäristöissä
EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)

EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN IEC 61000-6-2:2019 Sähkömagneettinen yhteensopivuus (EMC). Osa 6-2: Yleiset standardit. Häiriönsieto teollisuusympäristöissä
EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
IEC 60335-2-17:2005
IEC 60601-1-2:2001
IEC 60601-1:1988
IEC 61000-4-3:2006
ISO 10328:2006 Prosthetics -- Structural testing of lower-limb prostheses -- Requirements and test methods
ISO 13404:2007 Prosthetics and orthotics -- Categorization and description of external orthoses and orthotic components
ISO 13405-1:1996 Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 1: Classification of prosthetic components
ISO 13405-2:1996 Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 2: Description of lower-limb prosthetic components
ISO 13405-3:1996 Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 3: Description of upper-limb prosthetic components
ISO 15032:2000 Prostheses -- Structural testing of hip units
ISO 22675:2006 Prosthetics -- Testing of ankle-foot devices and foot units -- Requirements and test methods
ISO 8548-1:1989 Prosthetics and orthotics -- Limb deficiencies -- Part 1: Method of describing limb deficiencies present at birth
ISO 8548-2:1993 Prosthetics and orthotics -- Limb deficiencies -- Part 2: Method of describing lower limb amputation stumps
ISO 8548-3:1993 Prosthetics and orthotics -- Limb deficiencies -- Part 3: Method of describing upper limb amputation stumps
ISO 8549-1:1989 Prosthetics and orthotics -- Vocabulary -- Part 1: General terms for external limb prostheses and external orthoses
ISO 8549-2:1989 Prosthetics and orthotics -- Vocabulary -- Part 2: Terms relating to external limb prostheses and wearers of these prostheses
ISO 8549-3:1989 Prosthetics and orthotics -- Vocabulary -- Part 3: Terms relating to external orthoses

Tekninen komitea

CEN/TC 293 Assistive products and accessibility »

Direktiivi

93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

16.04.2007

Julkaisupäivä

04.05.2007

Painos

1

Sivumäärä

87

Julkaisun kieli

englanti