 IEC QUALITY ASSESSMENT SYSTEM (IECQ)
For rules and details of the IECQ visit www.iecq.org |
IECQ Certificate of Approval
Independent Testing Laboratory |
| IECQ Certificate No.: | IECQ-L NSAIUS 08.0001 | Issue No.: | 6 | Status: | Cancelled |
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| Supersedes: | IECQ-L NSAIUS 08.0001 Issue 5 | Issue Date: | 2015/08/03 | Org. Issue: | 2006/08/04 |
| CB Reference No.: | 1.72.0104 | Expiration: | 2018/08/02 | Cancel: | 2017/06/06 |
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Geneva Laboratories
1001 Proctor Dr.
Elkhorn, WI 53121
United States of America
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The organization, facilities and procedures have been assessed by the IECQ Certification Body in accordance with IECQ 03-1 and IECQ 03-6 for issuance of this certificate and found to be in conformity with the applicable requirements of the IECQ Independent Testing Laboratory Assessment Program Requirements Scheme and in respect of ISO/IEC 17025:2017 for the testing of component product under the IECQ.
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Scope:
Biocompatibility, microbiological, chemical, electronic, safety, and toxicological testing utilizing applicable International and U.S. standards for a variety of medical device, supplies, laboratory and diagnostic products. Chemical and electrical testing of electronic components and assemblies used in instruments. Tests include: Gram Stain, Ames Test, Hemolysis Test, Cytotoxicity Assay, Antimicrobial Effectiveness Test, Microbial Limits, Bacterial Endotoxin, Particle Count, Package Integrity, Sterility, Bioburden, Physico-chemical Test, Intracutaneous Test, Acute Systemic Toxicity Test, Ocular Irritation Test, Penile Mucosa Irritation Test, Closed Patch Sensitization, Dermal Sensitization, Intramuscular Implantation Test, Oral Mucosa Irritation, Vaginal Mucosa Irritation, Primary Skin Irritation, and Muscle Implantation Test.
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Issued by the Certification Body: National Standards Authority of Ireland, Inc. |
402 Amherst Street, Suite 100 NASHUA, NH 03063
United States
Authorised Person:
Kevin D Mullaney
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The validity of this certificate is maintained through on-going surveillance audits by the IECQ CB issuing this certificate. This Certificate of Conformity may be suspended or withdrawn in accordance with the
Rules of Procedure of the IECQ System and its Schemes.
This certificate and any schedule(s) may only be reproduced in full.
This certificate is not transferable and remains the property of the issuing IECQ CB.
The Status and authenticity of this certificate may be verified by visiting www.iecq.org.
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IECQ-L Rev. 10
- Attached Translation: none [ Add ] |