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About Asteral

Regulations & Standards

Asteral's Managed Equipment Service operates in accordance with the following guidelines and statutory regulations:

  • Managing Medical Devices MDA DB2006(05)
  • Relevant Health Technical Memoranda
  • The policies, rules, procedures and standards implemented by Healthcare Trusts
  • Controls Assurance Standards Medical Device Management 2002
  • Medical Device Regulations implications on healthcare and related establishments 1996
  • Single use medical devices MDA DB2000(04)
  • For the Record Managing Records in NHS Trusts and Health Authorities HSC 1999/53
  • Fully Equipped Audit Commission 2000
  • The Clinical Engineering Procedures Manual
  • Manufacturers' and Suppliers' Updates and Recommendations
  • Reporting Adverse Incidents and Disseminating Safety Warnings MDA SN2001(01)
  • Ionising Radiation Regulations 1999 and ACOP
  • Ionising Radiation Medical Exposure Regulations (IRMER 2000)
  • Safety testing to HEI95, IEC601 and IEC1010
  • Equipment Management from cradle to grave as HEI 98
  • Lifting Operations and Equipment Regulations (LOLER 1999)