BS EN ISO 15798:2010 - Ophthalmic implants. Ophthalmic viscosurgical devices – BSI British Standards

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BS EN ISO 15798:2010

Ophthalmic implants. Ophthalmic viscosurgical devices

Status : Revised, Superseded, Withdrawn   Published : February 2010 Replaced By :

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BS EN ISO 15798:2010 Ophthalmic implants. Ophthalmic viscosurgical devices

BS EN ISO 15798 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.

BS EN ISO 15798 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

BS EN ISO 15798:

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Characterization of the components
5.3 Characterization of the finished product
6 Design evaluation
6.1 General
6.2 Evaluation of biological safety
6.3 Clinical evaluation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
10.1 Protection from damage during storage and transport
10.2 Maintenance of sterility in transit
11 Information to be supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Patient numbers for clinical investigation of intra-ocular pressure
Bibliography

 




Standard NumberBS EN ISO 15798:2010
TitleOphthalmic implants. Ophthalmic viscosurgical devices
StatusRevised, Superseded, Withdrawn
Publication Date28 February 2010
Withdrawn Date30 September 2013
Cross ReferencesISO 10993-1, ISO 10993-2, ISO 10993-6, ISO 10993-9, ISO 10993-16, ISO 11135-1, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11607-1, ISO 13408-1, ISO 14155-1, ISO 14155-2, ISO 14630, ISO 14971, ISO 15223-1, ISO 15223-2, ISO 17665-1, ISO 22442-1, ISO 22442-2, ISO 22442-3, EN 980, EN 1041, 93/42/EEC
ReplacesBS EN ISO 15798:2001
International RelationshipsEN ISO 15798 (ISO 15798:2010),ISO 15798:2010 Ed 2
Draft Superseded By08/30178723 DC
DescriptorsPackaging, Instructions for use, Safety measures, Sterilization (hygiene), Ophthalmic equipment, Performance, Surgical equipment, Design, Implants (surgical), Medical equipment, Eyes, Ophthalmology
ICS11.040.70
Title in FrenchImplants ophtalmiques. Dispositifs ophtalmiques viscoélastiques
Title in GermanOphthalmische Implantate. Viskoelastische Substanzen
CommitteeCH/172/7
ISBN978 0 580 62222 9
PublisherBSI
FormatA4
DeliveryNo
Pages26
File Size563 KB
Price£176.00


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