1 ꯆꯍꯤ ꯱꯴ꯒꯤ ꯄ꯭ꯔꯣꯐꯦꯁ꯭ꯅꯦꯜ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯗꯤꯚꯥꯏꯁ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯦꯂꯁ ꯑꯦꯛꯁꯄꯤꯔꯤꯑꯦꯟꯁ ꯂꯩꯕꯥ꯫

2 ISO 13485:2016 ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯟ / ꯁꯤ.ꯏ.ꯒꯤ ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯟ (TÜVꯅꯥ ꯄꯤꯕꯥ)

1 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯀꯣꯄꯤꯁꯤꯡ ꯄꯤꯕꯥ꯫

꯲ ꯚꯤꯗꯤꯑꯣ ꯐꯦꯛꯇꯔꯤ ꯏꯟꯁꯄꯦꯛꯁꯅꯒꯤ ꯊꯧꯔꯥꯡ ꯇꯧꯕꯥ ꯌꯥꯏ꯫

ꯁ꯭ꯄꯥꯏꯅꯦꯜ ꯀꯣꯔꯗ, ꯏꯟꯠꯔꯥꯃꯦꯗꯨꯂꯦꯔꯤ ꯅꯦꯜ, ꯂꯣꯀꯤꯡ ꯄ꯭ꯂꯦꯇꯁꯤꯡ, ꯀꯟꯚꯦꯟꯁꯅꯦꯜ ꯄ꯭ꯂꯦꯇꯁꯤꯡ, ꯖꯣꯅꯁꯤꯡ, ꯁ꯭ꯄꯣꯔꯇꯁ ꯃꯦꯗꯤꯁꯤꯟ, ꯑꯦꯛꯁꯇꯔꯅꯦꯜ ꯐꯤꯛꯁꯦꯁꯟ, ꯏꯂꯦꯛꯠꯔꯤꯛ ꯗ꯭ꯔꯥꯏꯂꯁꯤꯡ, ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ꯫

꯱ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯑꯣꯇꯣꯃꯦꯁꯅꯒꯤ ꯆꯥꯡ ≥꯹꯵%

꯲ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ꯒꯤ ꯄ꯭ꯔꯗꯛꯁꯟ ꯀꯟꯠꯔꯣꯜ ꯄ꯭ꯔꯣꯁꯤꯖꯔꯁꯤꯡ ꯑꯀꯅꯕꯥ ꯃꯑꯣꯡꯗꯥ ꯏꯃꯞꯂꯤꯃꯦꯟꯇ ꯇꯧꯕꯥ꯫

꯳ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯔꯦꯀꯣꯔꯗ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯃꯄꯨꯡ ꯐꯥꯅꯥ ꯄꯥꯡꯊꯣꯀꯄꯥ꯫

1 ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯄ꯭ꯔꯗꯛꯇꯁꯤꯡ: ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.꯱ ꯄꯤꯁ꯫

꯲ ꯀꯁ꯭ꯇꯝ ꯄ꯭ꯔꯗꯛꯇꯁꯤꯡ: ꯀꯦꯁ ꯑꯃꯗꯒꯤ ꯀꯦꯁ ꯑꯃꯗꯥ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯕꯥ꯫

1 ꯆꯥꯡ ꯅꯥꯏꯅꯥ ꯑꯣꯔꯗꯔ ꯇꯧꯕꯥ: ꯊꯕꯛ ꯅꯨꯃꯤꯠ ꯷ꯅꯤꯒꯤ ꯃꯅꯨꯡꯗꯥ ꯊꯥꯕꯥ꯫

꯲ ꯈꯨꯗꯛꯀꯤ ꯑꯣꯏꯕꯥ ꯑꯣꯔꯗꯔꯁꯤꯡ: ꯅꯨꯃꯤꯠ ꯳-꯵ꯅꯤ (ꯁ꯭ꯇꯣꯛ ꯀꯅꯐꯔꯝ ꯇꯧꯕꯒꯤ ꯃꯈꯥ ꯄꯣꯜꯂ�ꯨꯅꯤꯂꯦꯇꯦꯔꯦꯜ, ꯕꯥꯏꯂꯦꯇꯔꯦꯜ, ꯑꯃꯁꯨꯡ ꯁꯔꯀꯨꯂꯥꯔ ꯐꯤꯛꯁꯦꯇꯔꯁꯤꯡꯅꯤ꯫ ꯇ��ꯉꯥꯟ ꯇꯣꯉꯥꯅꯕꯥ ꯄ꯭ꯂꯦꯅꯁꯤꯡꯗꯥ ꯄꯤꯅꯁꯤꯡ ꯍꯥꯄꯆꯤꯟꯗꯨꯅꯥ , ꯀꯅꯥꯒꯨꯝꯕꯥ ꯑꯃꯅꯥ ꯃꯜꯇꯤꯞꯂꯦꯅꯥꯔ ꯀꯟꯁꯠꯔꯛꯁꯟ ꯑꯃꯥ ꯁꯦꯝꯕꯥ ꯌꯥꯏ꯫ ꯌꯨꯅꯤꯞꯂꯥꯅꯥꯔ ꯐꯤꯛꯁꯦꯁꯟ ꯗꯤꯚꯥꯏꯁꯁꯤꯡ ꯑꯁꯤ ꯌꯥꯝꯅꯥ ꯊꯨꯅꯥ ꯑꯃꯁꯨꯡ ꯌꯥꯝꯅꯥ ꯂꯥꯏꯅꯥ ꯁꯤꯖꯤꯟꯅꯩ ꯑꯗꯨꯕꯨ ꯃꯜꯇꯤꯞꯂꯥꯅꯀꯅꯥꯒꯨꯝꯕꯥ ꯑꯃꯅꯥ ꯃꯜꯇꯤꯞꯂꯦꯅꯥꯔ ꯀꯟꯁꯠꯔꯛꯁꯟ ꯑꯃꯥ ꯁꯦꯝꯕꯥ ꯌꯥꯏ꯫ ꯌꯨꯅꯤꯞꯂꯥꯅꯥꯔ ꯐꯤꯛꯁꯦꯁꯟ ꯗꯤꯚꯥꯏꯁꯁꯤꯡ ꯑꯁꯤ ꯌꯥꯝꯅꯥ ꯊꯨꯅꯥ ꯑꯃꯁꯨꯡ ꯌꯥꯝꯅꯥ ꯂꯥꯏꯅꯥ ꯁꯤꯖꯤꯟꯅꯩ ꯑꯗꯨꯕꯨ ꯃꯜꯇꯤꯞꯂꯥꯅꯥꯔ ꯐꯤꯛꯁꯦꯁꯟꯒꯨꯝꯅꯥ ꯃꯄꯥꯉ꯭ꯒꯜ ꯀꯅꯕꯥ ꯑꯣꯏꯗꯦ꯫ ꯄꯤꯅꯁꯤꯡ ꯑꯁꯤ ꯁꯔꯨꯒꯤ ꯅꯥꯀꯜ ꯑꯅꯤꯃꯛꯇꯥ ꯂꯩꯕꯥ ꯃꯇꯃꯗꯥ ꯕꯥꯏꯂꯦꯇꯔꯦꯜ ꯐ꯭ꯔꯦꯃꯁꯤꯡ ꯁꯦꯝꯃꯤ ꯑꯃꯁꯨꯡ ꯃꯁꯤꯅꯥ ꯑꯍꯦꯅꯕꯥ ꯁ꯭ꯇꯦꯕꯤꯂꯤꯇꯤꯁꯨ ꯍꯥꯄꯆꯤꯅꯕꯥ ꯌꯥꯏ꯫ ꯁꯔꯀꯨꯂꯥꯔ ꯐꯤꯛꯁꯦꯇꯔꯁꯤꯡ ꯑꯁꯤ ꯂꯤꯝꯐ ꯂꯦꯡꯗꯅꯥ ꯂꯩꯍꯅꯕꯒꯤ ꯊꯧꯑꯣꯡꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯃꯤꯌꯥꯝꯅꯥ ꯄꯥꯝꯅꯕꯥ ꯑꯣꯏꯔꯛꯂꯤ ꯑꯗꯨꯕꯨ ꯑꯅꯥꯕꯥ ꯑꯗꯨꯕꯨ ꯑꯔꯨꯝꯕꯥ ꯂꯧꯕꯥ ꯌꯥꯍꯅꯕꯗꯥ ꯑꯃꯁꯨꯡ ꯂꯥꯌꯦꯡꯕꯒꯤ ꯃꯇꯃꯗꯥ ꯖꯣꯏꯟꯇ ꯃꯣꯁꯟ ꯈꯔꯥ ꯊꯝꯕꯥ ꯌꯥꯍꯅꯕꯗꯥ ꯃꯔꯨꯑꯣꯏꯅꯥ ꯏꯐꯦꯛꯇꯤꯕ ꯑꯣꯏ꯫ ꯃꯈꯣꯌ ꯑꯁꯤ ꯁꯤꯖꯤꯟꯅꯕꯗꯥ ꯍꯦꯟꯅꯥ ꯂꯨꯝꯃꯤ ꯑꯃꯁꯨꯡ ꯑꯄꯤꯀꯄꯥ ꯒꯦꯖ ꯄꯤꯅꯁꯤꯡ ꯁꯤꯖꯤꯟꯅꯩ ꯑꯃꯁꯨꯡ ꯃꯈꯣꯌ ꯑꯁꯤ ꯑꯔꯨꯝꯕꯥ ꯌꯦꯟꯊꯣꯀꯄꯗꯥ ꯍꯦꯟꯅꯥ ꯁꯤꯖꯤꯟꯅꯩ꯫

1 ꯏꯟꯇꯔꯅꯦꯁ꯭ꯅꯦꯜ ꯑꯦꯛꯁꯞꯔꯦꯁ (ꯗꯤ.ꯑꯩꯆ.ꯑꯦꯜ./ꯐꯦꯗꯑꯦꯛꯁ/ꯌꯨ.ꯄꯤ.ꯑꯦꯁ.): ꯅꯨꯃꯤꯠ ꯷-꯱꯵ꯅꯤ꯫

꯲ ꯑꯦꯌꯔ ꯐ꯭ꯔꯦꯠ: 0ꯅꯨꯃꯤꯠ ꯱ -꯲꯵ꯅꯤ꯫

1 ꯄ꯭ꯔꯣꯐꯦꯁ꯭ꯅꯦꯜ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ ꯇꯤꯃꯅꯥ ꯃꯄꯨꯡ ꯐꯥꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯁꯄꯣꯔꯠ ꯄꯤꯔꯤ
2 ꯁꯥꯏꯟꯇꯤꯐꯤꯛ ꯁꯤꯄꯤꯡ ꯁꯣꯂꯨꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯀꯁ꯭ꯇꯃꯁ ꯀ꯭ꯂꯤꯌꯔꯦꯟꯁꯀꯤ ꯃꯇꯦꯡ ꯄꯤꯔꯤ꯫

ꯑꯦꯛꯁꯞꯔꯦꯁ/ꯑꯦꯌꯔ ꯐ꯭ꯔꯦꯠ: ꯑꯣꯔꯗꯔ ꯑꯗꯨꯒꯤ ꯇꯁꯦꯡꯕꯥ ꯑꯔꯨꯝꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯚꯣꯜꯌꯨꯃꯦꯠꯔꯤꯛ ꯑꯣꯏꯕꯥ ꯑꯔꯨꯝꯕꯥ ꯑꯗꯨꯅꯥ ꯆꯥꯔꯖ ꯇꯧꯏ꯫

1 ꯁꯤꯄꯃꯦꯟꯇ ꯇꯧꯗ꯭ꯔꯤꯉꯩꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯄ꯭ꯔꯗꯛꯇꯀꯤ ꯐꯣꯇꯣꯁꯤꯡ ꯄꯤꯕꯥ꯫

2 ꯏꯟꯇꯔꯅꯦꯁ꯭ꯅꯦꯜ ꯇ꯭ꯔꯦꯀꯤꯡ ꯅꯝꯕꯔ ꯄꯤꯕꯥ (ꯔꯤꯑꯦꯜ-ꯇꯥꯏꯝ ꯇ꯭ꯔꯦꯀꯤꯡ ꯑꯁꯤ ꯑꯣꯟ...