Legal documents important to PET Radiochemistry

Title Keywords Enforcement area Publishing date
2009 EANM parathyroid guidelines EANM EU 12 May 2009
A step by step guide to COSHH assessment UK 1 Jan 2004
Approved Classification and Labelling Guide (Sixth edition) UK 1 Jan 2009
BS ISO 27001-2005 Information technology-Security techniques ISO global 18 Oct 2005
CHIP for everyone UK 1 Jan 2002
Commission Directive 2000/39/EC First list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC occupational exposure limit values EU 8 Jun 2000
Commission Directive 2006/15/EC Second list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC occupational exposure limit values EU 7 Feb 2006
Council Directive 89/391/EEC Introduction of measures to encourage improvements in the safety and health of workers at work EU 12 Jun 1989
Council Directive 89/392/EEC Approximation of the laws of the Member States relating to machinery EU 14 Jun 1989
Council Directive 89/654/EEC Minimum safety and health requirements for the workplace EU 30 Nov 1989
Council Directive 89/655/EEC Minimum safety and health requirements for the use of work equipment by workers at work EU 30 Nov 1989
Council Directive 89/656/EEC Minimum health and safety requirements for the use by workers of personal protective equipment at the workplace EU 30 Nov 1989
Council Directive 90/269/EEC Minimum health and safety requirements for the manual handling of loads where there is a risk particularly of back injury to workers EU 29 May 1990
Council Directive 90/270/EEC Minimum safety and health requirements for work with display screen equipment EU 29 May 1990
Council Directive 98/24/EC Protection of the health and safety of workers from the risks related to chemical agents at work chemical agents, occupational exposure limit values EU 7 Apr 1998
Directive 2001/83/EC Community code relating to medicinal products for human use EU 6 Nov 2001
Directive 2003/10/EC Minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) EU 6 Feb 2003
Directive 2008/1/EC Integrated Pollution Prevention and Control (IPPC Directive) new installations EU 15 Jan 2008
EANM procedure guidelines for brain neurotransmission SPECT/PETusing dopamine D2 receptor ligands, version2 EANM EU 19 Oct 2009
EANM Procedure Guidelines for Brain Tumour Imaging using Labelled Amino Acid Analogues EANM EU 16 May 2006
EANM procedure guidelines for PET brain imaging using [18 F]FDG, version2 EANM EU 17 Oct 2009
EANM/ESC guidelines for radionuclide imaging of cardiac function EANM EU 1 Jan 2008
EANM/ESCproceduralguidelinesformyocardialperfusion imaginginnuclearcardiology EANM EU 7 Jul 2005
Environment Act 1995 air, pollution, water UK 19 Jul 1995
Environmental Protection Act 1990 discharges, emissions UK 1 Nov 1990
FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version1.0 EANM EU 17 Nov 2009
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems ISPE global 29 Feb 2008
Guideline to Regulations for Radiopharmaceuticals in Early Phase Clinical Trials in the EU EANM EU 1 Jan 2008
Guidelines for 18 F-FDG PETand PET-CT imaging in paediatric oncology EANM EU 1 Jan 2008
Guidelines on cGRPP in the Preparation of Radiopharmaceuticals EANM EU 2 Mar 2007
ICH Q10 Pharmacutical Quality System ICH global 4 Jun 2008
ICH Q2(R1) Validation of Analytical Procedures ICH global 30 Nov 2005
ICH Q3C(R3) Impurities - Guideline for Residual Solvents ICH global 30 Nov 2005
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients ICH global 10 Nov 2000
ICH Q9 Quality Risk Management ICH global 9 Nov 2005
ISO 10648-1:1997 Containment enclosures-Part 1: Design principles ISO global 1 May 1997
ISO 10648-2:1994 Containment enclosures-Part 2: Classification according to leak tightness and associated checking methods ISO global 1 Dec 1994
ISO 14644-1-1999 Cleanrooms and associated controlled environments-Part 1 Classification of air cleanliness ISO global 15 Aug 1999
ISO 14644-2-2000 Cleanrooms and associated controlled environments-Part 2 Specifications for testing and monitoring ISO global 15 Dec 2000
ISO 14644-3-2005 Cleanrooms and associated controlled environments-Part 3 Test methods ISO global 20 Dec 2005
ISO 14644-4-2001 Cleanrooms and associated controlled environments-Part 4 Design, construction and start-up ISO global 15 Sep 2001
ISO 14644-5-2004 Cleanrooms and associated controlled environments-Part 5 Operations ISO global 20 Aug 2004
ISO 14644-6-2007 Cleanrooms and associated controlled environment-Part 6 Vocabulary ISO global 31 Aug 2007
ISO 14644-7-2004 Cleanrooms and associated controlled environments-Part 7 Separative devices ISO global 14 Aug 2008
ISO 14644-8-2006 Cleanrooms and associated controlled environments-Part 8 Classification of airborne molecular contamination ISO global 29 Sep 2006
ISO 9000-2005 Quality management systems - Fundamentals and vocabulary ISO global 29 Sep 2005
ISO 9001-2008 Quality management systems - Requirements ISO global 30 Nov 2008
ISO 9004-2000 Quality management systems - Guidelines for performance improvements ISO global 15 Dec 2000
ISPE - Commissioning and Qualification Baseline Guide Commissioning, Qualification global 1 Mar 2001
Making sense of NONS UK 1 Jan 1994