Already a subscriber? 

MADCAD.com Free Trial
Sign up for a 3 day free trial to explore the MADCAD.com interface, PLUS access the
2009 International Building Code to see how it all works.
If you like to setup a quick demo, let us know at support@madcad.com
or +1 800.798.9296 and we will be happy to schedule a webinar for you.
Security check
Please login to your personal account to use this feature.
Please login to your authorized staff account to use this feature.
Are you sure you want to empty the cart?
S+ IEC 60601-2-68 Ed. 2.0 en:2025 (Redline version) Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, lig, 2025
- Redline version (English only) [Go to Page]
- CONTENTS
- FOREWORD
- INTRODUCTION
- 201.1 Scope, object and related standards
- 201.2 Normative references
- 201.3 Terms and definitions
- 201.4 General requirements
- 201.5 General requirements for testing me equipment
- 201.6 Classification of me equipment and me systems
- 201.7 Me equipment identification, marking and documents
- 201.8 Protection against electrical hazards from me equipment
- 201.9 Protection against mechanical hazards of me equipment and me systems
- 201.10 Protection against unwanted and excessive radiation hazards
- 201.11 Protection against excessive temperatures and other hazards
- 201.12 Accuracy of controls and instruments and protection against hazardous outputs
- 201.13 Hazardous situations and fault conditions for me equipment
- 201.14 Programmable electrical medical systems (pems)
- 201.15 Construction of me equipment
- 201.16 Me systems
- 201.17 Electromagnetic compatibility of me equipment and me systems
- 201.101 Reference data for x-igrt
- 201.102 X-igrt imaging
- 201.103 Igrt analysis and correction
- 201.104 Operation of me equipment parts from outside the facility
- 203 Radiation protection in diagnostic X-ray equipment
- 206 Usability
- Annexes [Go to Page]
- Annex A (informative) Sequence of testing
- Annex I (informative) Me systems aspects
- Annex AA (informative) Particular guidance and rationale
- Annex BB (informative) Measuring CTDIfree air
- Bibliography
- Index of defined terms used in this document
- Figures [Go to Page]
- Figure 201.101 – Patient support movements
- Figure AA.1 – Signals related to igrt latency
- Tables [Go to Page]
- Table 201.101 – Data required in the technical description
- Table 201.102 – Clauses and subclauses in this document that require the provision of information in the accompanying documents documentation, instructions for use and the technical description
- Table 201.103 – Example test pattern for ctdifree air for kV
- Table AA.1 – Clauses of the standard that contain requirements for x-igrt imaging components and related clauses of IEC 60601-2-44 and IEC 60601-2-54 with equivalent requirements for CT scanner, x-ray equipment for radiography, and x-ray equipment for radioscopy
- International Standard (Bilingual) [Go to Page]
- English [Go to Page]
- CONTENTS
- FOREWORD
- INTRODUCTION
- 201.1 Scope, object and related standards
- 201.2 Normative references
- 201.3 Terms and definitions
- 201.4 General requirements
- 201.5 General requirements for testing me equipment
- 201.6 Classification of me equipment and me systems
- 201.7 Me equipment identification, marking and documents
- 201.8 Protection against electrical hazards from me equipment
- 201.9 Protection against mechanical hazards of me equipment and me systems
- 201.10 Protection against unwanted and excessive radiation hazards
- 201.11 Protection against excessive temperatures and other hazards
- 201.12 Accuracy of controls and instruments and protection against hazardous outputs
- 201.13 Hazardous situations and fault conditions for me equipment
- 201.14 Programmable electrical medical systems (pems)
- 201.15 Construction of me equipment
- 201.16 Me systems
- 201.17 Electromagnetic compatibility of me equipment and me systems
- 201.101 Reference data for x-igrt
- 201.102 X-igrt imaging
- 201.103 Igrt analysis and correction
- 201.104 Operation of me equipment parts from outside the facility
- 203 Radiation protection in diagnostic X-ray equipment
- 206 Usability
- Annexes [Go to Page]
- Annex A (informative) Sequence of testing
- Annex I (informative) Me systems aspects
- Annex AA (informative) Particular guidance and rationale
- Annex BB (informative) Measuring CTDIfree air
- Bibliography
- Index of defined terms used in this document
- Figures [Go to Page]
- Figure AA.1 – Signals related to igrt latency
- Tables [Go to Page]
- Table 201.101 – Data required in the technical description
- Table 201.102 – Clauses and subclauses in this document that require the provision of information in the accompanying documentation, instructions for use and the technical description
- Table 201.103 – Example test pattern for ctdifree air for kV
- Table AA.1 – Clauses of the standard that contain requirements for x-igrt imaging components and related clauses of IEC 60601-2-44 and IEC 60601-2-54 with equivalent requirements for CT scanner, x-ray equipment for radiography, and x-ray equipment for radioscopy
- Français [Go to Page]
- SOMMAIRE
- AVANT-PROPOS
- INTRODUCTION
- 201.1 Domaine d'application, objet et normes connexes
- 201.2 Références normatives
- 201.3 Termes et définitions
- 201.4 Exigences générales
- 201.5 Exigences générales relatives aux essais des appareils em
- 201.6 Classification des appareils em et des systèmes em
- 201.7 Identification, marquage et documentation des appareils em
- 201.8 Protection contre les dangers d'origine électrique provenant des appareils em
- 201.9 Protection contre les dangers mécaniques des appareils em et des systèmes em
- 201.10 Protection contre les dangers dus aux rayonnements involontaires ou excessifs
- 201.11 Protection contre les températures excessives et les autres dangers
- 201.12 Précision des commandes et des instruments et protection contre les caractéristiques de sortie présentant des risques
- 201.13 Situations dangereuses et conditions de défaut pour les appareils em
- 201.14 Systèmes électromédicaux programmables (semp)
- 201.15 Construction de l'appareil em
- 201.17 Compatibilité électromagnétique des appareils et des systèmes em
- 201.101 Données de référence pour la radiothérapie à rayonnement X assistée par imagerie médicale
- 201.102 Imagerie X-igrt
- 201.103 Analyse igrt et correction
- 201.104 Fonctionnement des parties d'appareils em depuis l'extérieur de l'installation
- 203 Radioprotection dans les appareils à rayonnement X de diagnostic
- 206 Aptitude à l'utilisation
- Annexes [Go to Page]
- Annexe A (informative) Ordre des essais
- Annexe I (informative) Aspects des systèmes em
- Annexe AA (informative) Recommandations particulières et justifications
- Annexe BB (informative) Mesures de CTDIair libre
- Bibliographie
- Index des termes définis utilisés dans le présent document
- Figures [Go to Page]
- Figure AA.1 – Signaux associés à la latence igrt
- Tableaux [Go to Page]
- Tableau 201.101 – Données exigées dans la description technique
- Tableau 201.102 – Articles et paragraphes du présent document pour lesquels des informations doivent être indiquées dans la documentation d'accompagnement, les instructions d'utilisation et la description technique
- Tableau 201.103 – Exemple de modèle d'essai pour ctdiair libre pour kV
- Tableau AA.1 – Articles et paragraphes de la norme qui contiennent des exigences pour les composantes d'imagerie x-igrt et articles et paragraphes correspondants de l'IEC 60601-2-44 et l'IEC 60601-2-54 avec les exigences équivalentes pour les tomodensitomètres, les appareils à rayonnement x pour la radiographie et les appareils à rayonnement x pour la radioscopie [Go to Page]