| Directive Area: | Active implantable medical devices
90/385/EEC
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| CEN Technical Body: | Biological evaluation of medical devices (CEN/TC 206) |
| List of 12 mandated standardization projects found for your selection criteria |
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206043 | EN ISO 10993-1:2009 | 90/385/EEC | CEN/TC 206 | 9/17/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206044 | EN ISO 10993-10:2010 | 90/385/EEC | CEN/TC 206 | 7/23/2010 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206061 | EN ISO 10993-11:2009 | 90/385/EEC | CEN/TC 206 | 4/12/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206062 | EN ISO 10993-12:2009 | 90/385/EEC | CEN/TC 206 | 4/12/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206042 | EN ISO 10993-13:2010 | 90/385/EEC | CEN/TC 206 | 6/5/2010 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206057 | EN ISO 10993-17:2009 | 90/385/EEC | CEN/TC 206 | 4/12/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206058 | EN ISO 10993-18:2009 | 90/385/EEC | CEN/TC 206 | 4/12/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206049 | EN ISO 10993-4:2009 | 90/385/EEC | CEN/TC 206 | 4/28/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206035 | EN ISO 10993-5:2009 | 90/385/EEC | CEN/TC 206 | 4/17/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206060 | EN ISO 10993-6:2009 | 90/385/EEC | CEN/TC 206 | 4/28/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206023 | EN ISO 10993-7:2008 | 90/385/EEC | CEN/TC 206 | 9/23/2008 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) | ||||||
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Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00206041 | EN ISO 10993-9:2009 | 90/385/EEC | CEN/TC 206 | 11/18/2009 | Ratified | ||
| Title of standard | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) | ||||||
Data loaded from the CEN Management Centre database on 9/2/2010 6:12:59 AM