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EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 No. CE 01530 Issued To: STERIS Corporation 5960 Heisley Road Mentor Ohio 44060 USA In respect of: The design and manufacture of sterile processing equipment, infection prevention systems and sterilant and disinfectant chemical products for use with equipment for the sterilization and/or high level disinfection of medical devices. on the basis of our examination of the quality assurance system under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For the placing on the market of class III products an Annex II section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086): Pietro Foschi - Strategic Delivery Director First Issued: 20 January 1997 Date: 10 April 2015 Expiry Date: 10 July 2018 Page 1 of 1 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.

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Page 1: E C C e r t i f i c a t e - F u l l Q u a l i ty A s s u ... n d s t e r i l a n t a n d d i s i n f e c t a n t c h e m i c a l p r o d u c t s f o r u s e w i t h e q u i p m e n

EC Certificate - Full Quality Assurance SystemDirective 93/42/EEC on Medical Devices, Annex II excluding Section 4

No. CE 01530Issued To: STERIS Corporation

5960 Heisley RoadMentorOhio44060USA

In respect of:

The design and manufacture of sterile processing equipment, infection prevention systemsand sterilant and disinfectant chemical products for use with equipment for the sterilizationand/or high level disinfection of medical devices.

on the basis of our examination of the quality assurance system under the requirements of Council Directive93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. Forthe placing on the market of class III products an Annex II section 4 certificate is required.

For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086):

Pietro Foschi - Strategic Delivery Director

First Issued: 20 January 1997 Date: 10 April 2015 Expiry Date: 10 July 2018

Page 1 of 1

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the requiredsurveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the companynamed on this certificate, unless specifically agreed with BSI.This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Page 2: E C C e r t i f i c a t e - F u l l Q u a l i ty A s s u ... n d s t e r i l a n t a n d d i s i n f e c t a n t c h e m i c a l p r o d u c t s f o r u s e w i t h e q u i p m e n

Steris Canada Corporation490 Boulevard Armand-ParisQuébecQuébecG1C 8A3Canada

Manufacture

STERIS Corporation6100 Heisley RoadMentorOhio44060USA

Manufacture

STERIS Corporation6515 Hopkins RoadMentorOhio 44060USA

Manufacture

EC Certificate - Full Quality Assurance SystemDirective 93/42/EEC on Medical Devices, Annex II excluding Section 4

List of Significant SubcontractorsRecognised as being involved in services relating to the product covered by:

Certificate No: CE 01530Date: 10 April 2015Issued To: STERIS Corporation

5960 Heisley RoadMentorOhio44060USA

Subcontractor: Service(s) supplied

Page 1 of 2

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Page 3: E C C e r t i f i c a t e - F u l l Q u a l i ty A s s u ... n d s t e r i l a n t a n d d i s i n f e c t a n t c h e m i c a l p r o d u c t s f o r u s e w i t h e q u i p m e n

STERIS CorporationPinecone DriveMentorOhio 44060USA

Manufacture

STERIS Ltd.Chancery House190 Waterside RoadHamilton Industrial ParkLeicester LE5 1QZUnited Kingdom

EU Representative

STERIS MEXICO, S.de R.L. de C.V.Avenida Avante 790Parque Industrial GuadalupeGuadalupeNuevo León67190Mexico

Manufacture

EC Certificate - Full Quality Assurance SystemDirective 93/42/EEC on Medical Devices, Annex II excluding Section 4

List of Significant SubcontractorsRecognised as being involved in services relating to the product covered by:

Certificate No: CE 01530Date: 10 April 2015Issued To: STERIS Corporation

5960 Heisley RoadMentorOhio44060USA

Subcontractor: Service(s) supplied

Page 2 of 2

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Page 4: E C C e r t i f i c a t e - F u l l Q u a l i ty A s s u ... n d s t e r i l a n t a n d d i s i n f e c t a n t c h e m i c a l p r o d u c t s f o r u s e w i t h e q u i p m e n

EC Certificate - Full Quality Assurance System

Certificate History

Certificate No: CE 01530Date: 10 April 2015Issued To: STERIS Corporation

5960 Heisley RoadMentorOhio44060USA

Page 1 of 1

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the requiredsurveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the companynamed on this certificate, unless specifically agreed with BSI.This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Date ReferenceNumber Action

20 January 1997 First Issue

09 July 2003 5 year renewal and addition of UK site for EU Regulatory activities(Vigilance)

16 March 2006 Scope clarification and the addition of disinfectants

11 July 2008 7236989 Certificate renewal and additional sub-contractor ‘STERIS MEXICO’

28 September 2012 7905781 Replacement of EU Representative with STERIS Ltd., Leicester, UK

16 May 2013 7944025 Certificate renewal

10 April 2015 8286661 Addition of Steris Canada Corporation and another STERISCorporation location in Mentor, Ohio (6100 Heisley Road) assignificant subcontractors for manufacture.


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