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11.040.01 Medical equipment in general
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116.11 USD
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116.11 USD
UNE EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Released: 2018-12-26
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132.00 USD
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132.00 USD
Spanish PDF
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110.00 USD
Spanish Hardcopy
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110.00 USD
UNE EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Released: 2018-05-16
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102.67 USD
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102.67 USD
Spanish PDF
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85.56 USD
Spanish Hardcopy
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85.56 USD
UNE EN ISO 10993-7:2009
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Released: 2009-06-03
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190.67 USD
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190.67 USD
Spanish PDF
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158.89 USD
Spanish Hardcopy
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158.89 USD
English PDF
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76.27 USD
English Hardcopy
In stock
76.27 USD
Spanish PDF
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63.56 USD
Spanish Hardcopy
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63.56 USD
UNE EN ISO 10993-7:2009/AC:2010
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
Released: 2010-02-24
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2.43 USD
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2.43 USD
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2.43 USD
Spanish Hardcopy
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2.43 USD
UNE EN ISO 13485:2018
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
Released: 2018-07-25
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168.67 USD
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168.67 USD
Spanish PDF
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140.56 USD
Spanish Hardcopy
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140.56 USD
UNE EN ISO 13485:2018/A11:2022
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Released: 2022-09-21
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108.53 USD
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108.53 USD
Spanish PDF
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90.44 USD
Spanish Hardcopy
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90.44 USD
UNE EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Released: 2021-09-22
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202.40 USD
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202.40 USD
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168.67 USD
Spanish Hardcopy
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168.67 USD
UNE EN ISO 14971:2020
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Released: 2020-09-23
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134.93 USD
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134.93 USD
Spanish PDF
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112.44 USD
Spanish Hardcopy
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112.44 USD
UNE EN ISO 14971:2020/A11:2022
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Released: 2022-06-22
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76.27 USD
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76.27 USD
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63.56 USD
Spanish Hardcopy
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63.56 USD
UNE EN ISO 15223-1:2022
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Released: 2022-03-16
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162.80 USD
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162.80 USD
Spanish PDF
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135.67 USD
Spanish Hardcopy
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135.67 USD