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TESTING OF STERILIZERS

PARTICULAR SPECIFICATION

1. REGULATIONS

All work shall be carried out in accordance with.

1.01 All relevant Acts or Parliament, statutory instruments and regulations.

1.02 Any public health, security and conduct requirements as from time to time be issued to the Contractor by the Employer.

1.03 Any relevant Safety Regulations published by the Employer copies of which are available from the Project Manager.

2. COMPLIANCE WITH BRITISH STANDARDS

2.01 All work and material shall company with relevant European and British Standards and Codes of Practice.

3. RESPONSIBILITIES OF THE EMPLOYER The Employer shall be responsible for:

3.01 The keeping of each item of Mechanical and Electrical Plant in such a condition that its functions in accordance with the requirements of SHTM 2010, BS 3970, BS 2646 and BS 3421.

3.02 Arranging for statutory inspections to be carried out (under a separate contract).

3.03 Maintenance of a record for each item of Mechanical and Electrical Plant in accordance with the requirements of SHTM 2010.

This shall contain details of all maintenance and remedial works carried out on each item of equipment to the following standards:

A. Failures Date

Symptoms of failure

B. Visits by other Contractors Date

Details of Work carried out including details of tests and replacements.

Date and time of completion C. Statutory Inspections Date

Details of any remedial work required.

Signature of competent person carrying out inspection.

4. INSTRUCTIONS

4.01 The Person from whom the Contractor will be required to accept instructions and attend any urgent or necessary recommissioning is listed in the Abstract of Particulars.

4.02 All requisitions for emergency action will be made by telephone to the Contractor’s office or central control point and will be confirmed in writing within 7 days by the Project Manager.

5. DOCUMENTATION

5.01 The Contractor must ensure that on each occasion his staff enter the details of any work carried out on the plant in the Plant History Record before leaving the site.

5.02 The Contractor, within 14 days of the completion of the tests, shall supply the Project Manager with a Test Report carried out under this contract as detailed in Appendix D, together with 3 copies.

6. DESCRIPTION OF THE WORK

6.0l The Contractor shall undertake annual tests as described in Appendix B – Testing Philosophy & Procedures and Appendix C - Annual Performance Tests on those Sterilizers listed in Appendix A - Sterilizer Inventory.

6.02 The Contractor shall employ persons, experienced, qualified and preferably certified to a minimum City and Guilds standard, who would be competent to perform all the required tests, documentary evidence of this shall be

provided. The Employer may require the said persons to demonstrate his/her competence by performing a test laid down by the Project Manager, to be witnessed by Project Manager or his/her nominated representative, prior to the letting of the Contract or during the period of the Contract.

6.03 The Contractor shall demonstrate that he has all the necessary equipment which is detailed in Part 3, Paragraph 6.1 – 6.63 of the current edition of Scottish Health Technical Memorandum 2010 (SHTM) and either evidence of its calibration or the means of verifying its calibration.

Current certification of accuracy traceable to the National Physical

Laboratory and where appropriate to NAMAS Standards will be required.

6.04 The Contractor shall prepare a schedule of the order and time in which he would perform the tests on the Sterilizers listed in Appendix A, to be agreed by the Project Manager prior to the awarding of the Contract.

6.05 The Contractor will confirm his intention to perform the scheduled test with the Project Manager or his/her nominated representative 14 days in

advance.

6.06 The Project Manager or his nominated representative will arrange for the Local Maintenance Engineer to be available to rectify any faults which the Contractor identifies during the test.

6.07 The Contractor shall on completion of an annual test, make a signed and dated entry in the Plant History Record that the Sterilizer complies or does not comply, with the performance requirements. In the event of non-compliance the Contractor shall notify the Project Manager or his local nominated representative (normally a departmental manager) within 24 hours.

6.08 The Contractor shall issue to the Project Manager, or his/her nominated representative, within 21 days of any test being carried out, the results of the tests in a test report as demonstrated in Appendix D together with 3 copies.

6.09 The Contractor shall satisfy himself from the Plant History Records of each Sterilizer give the service maintenance records, and where appropriate, the microbiological records for all routine tests and ascertain they have been performed on each Sterilizer throughout the previous year and is in a condition in which tests can be undertaken safely. Comments shall be included in the Test report.

6.10 The Contractor shall nominate on Appendix 2: Schedule of Contractor’s Particulars a representative who will act for the Contractor to liaise with the Project Manager on all matters relating to the Contract.

6.11 The Project Manager will take up any problems of the Contract with the Project Manager or his/her nominated representative.

6.12 The Project Manager or his/her nominated representative may visit any site at any time to inspect the Contractor’s test procedures and results.

6.13 The Contractor when requested, on the appropriate form (See Appendix E) will be required to retest any sterilizer that has not satisfactorily passed the annual test criteria.

Repeat tests will be paid for at not more than the cost of the test original of the said Sterilizer as listed in Appendix A, unless investigative testing has been previously agreed.

6.14 The Contractor shall confirm a date for retesting of sterilizers within two days of receiving the request and should carry out the retesting of Sterilizers where applicable within 10 working days of receiving the request.

Appendix A